4056 FIRST AID KIT- 4056 first aid kit 
4068 FIRST AID KIT- 4068 first aid kit 
4088 FIRST AID KIT- 4088 first aid kit 
4089 FIRST AID KIT- 4089 first aid kit 
4081 FIRST AID KIT- 4081 first aid kit 
4090 FIRST AID KIT- 4090 first aid kit 
4083 FIRST AID KIT- 4083 first aid kit 
4087 FIRST AID KIT- 4087 first aid kit 
4082 FIRST AID KIT- 4082 first aid kit 
4084 FIRST AID KIT- 4084 first aid kit 
4085 FIRST AID KIT- 4085 first aid kit 
4086 FIRST AID KIT- 4086 first aid kit 
Honeywell Safety Products USA, INC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

4056, 4068, 4081, 4082, 4083, 4084, 4085, 4086, 4087, 4088, 4089, 4090 First Aid Kit (Eye Wash, BCM- Z019851, SF00001232, Z019702-0002L, Z019704-0003L, 019702-0002L, 019703-0002L, 019703-4503, 019704-0003L, 019704-4504, 019705-4505, Z019707-0004L, 019706-0004L)

Active ingredient

Sterile Water 99%

Purpose

Eyewash

Uses

Warnings

For external use only- Obtain immediate medical treatment for all open wounds in or near the eyes. To avoid contamination, do not touch tip of container to any surface. Do not reuse. Once opened, discard.

Do not use

  • if solution changes color or becomes cloudy
  • if you have open wounds in or near the eyes, get medical help right away

Stop use and ask a doctor if

  • you experience eye pain
  • changes in vision
  • continued redness or irritation of the ey
  • condition worsens or persists

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive Ingredients

sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

Questions?

Call 1-800-430-5490

Honeywell Safety Products USA, Inc. Smithfield, RI 02917

First Aid Burn Cream
Active ingredient

Benzalkonium chloride o.13%

Lidocaine HCl 0.5%

First Aid Burn Cream
Purpose

First aid antiseptic

External analgesic

First Aid Burn Cream
Uses

First Aid Burn Cream
Warnings

For external use only

Do not use

  • in or near the eyes
  • if you are allergic to any of the ingredients
  • in large areas of the body, particularly over raw surfaces or blistered areas
  • for more than 10 days


Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occurs again within a few days

First Aid Burn Cream
Directions

Other information

Inactive ingredients

aloe barbadensis juice, cetyl alcohol, diazolidinyl urea, edetate disodium, glycerin, glyceryl stearate SE, methylparaben, mineral oil, PEG-100, propylene glycol, propylparaben, stearic acid, trolamine, water

Questions

1-800-430-5490

BZK Antiseptic Wipe
Active ingredient

Benzalkonium chloride 0.13%

BZK
Purpose

First aid antiseptic

BZK
Uses

Antiseptic cleansing of face, hands, and body without soap and water

BZK
Warnings

For external use only

BZK
Do not use

  • in the eyes or over large areas of the body
  • on mucous membranes
  • on irritated skin
  • in case of deep puncture wounds, animal bites or serious burns, consult a doctor
  • longer than 1 week unless directed by a doctor

Stop use and ask a doctor if

  • if irritation, redness or other symptoms develop
  • the condition persists or gets worse

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

BZK
Directions

BZK
Other information

BZK
Inactive ingredients

water

BZK
Questions

1-800-430-5490

Aypanal
Active igredient

Acetaminophen 325 mg

Aypanal
Purpose

Pain reliever/fever reducer

Aypanal
Uses

Ask a doctor before use if you have

liver disease

Aypanal
Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 4,000 mg in 24 hours, which is the maximum daily amount - child takes

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have

liver disease

Ask a doctor or pharmacist before use if

you are taking the blood thinning drug warfarin

if preganat or breast feeding

ask a health professional before use

Keep out of rech of children

Keep out of reach of children

Overdose Warning

Overdose warning: In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Aypanal
Directions

adults and children 12 years of age or older

Aypanal
Other information

store at room temperature 15 o to 30 o C (59 o - 86 oF) TAMPER EVIDENT PACKETS- DO NOT USE IF OPEN OR TORN

Aypanal
Inactive ingredients

corn starch, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid.

Aypanal
Questions or Comments?

1-800-430-5490

Sting Relief
Active ingredient

Ethyl alcohol 50.0%

Lidocaine HCl 2.0%

Sting Relief
Purpose

Antiseptic

Topical pain relief

Sting Relief
Uses

Sting Relief
Warnings


For external use only

Flammable, keep away from open fire or flame

Do not use

  • over large areas of the body
  • in eyes
  • over raw or blistered areas

Stop use and ask a doctor

  • if conditions worsen or persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Sting Relief
Directions

Sting Relief
Inactive ingredients

benzalkonium chloride, menthol, and purified water

Sting relief
Questions or Comments

1-800-430-5490

Neomycin Antibiotic Ointment
Active ingredient

Neomycin sulfate (5 mg equivalent to 3.5 mg Neomycin base)

Neomycin Antibiotic Ointment
Purpose

First aid antibiotic

Neomycin Antibiotic Ointment
Uses

first aid to help prevent infection in - minor cuts - scrapes - burns

Neomycin Antibiotic Ointment
Warnings

For external use only

Do not use

  • in the eyes
  • over large areas of the body

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

  • the condition persists or gets worse
  • a rash or other allergic reaction develops
  • you need to use longer than 1 week

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Neomycin Antibiotic Ointment
Directions

Neomycin Antibiotic Ointment
Other information

store at 15 o to 25 oC (59 o to 77 oF)

Neomycin Antibiotic Ointment
Inactive ingredient

petrolatum

Neomycin Antibiotic Ointment
Questions

1-800-430-5490

4056
Z019851 Kit Contents

1 TWEEZER PLASTICS 4"

1 FIRST AID GUIDE ASHI

2 GAUZE CLEAN-WRAP BDGE N/S 2"

1 GAUZE CLEAN-WRAP BDGE N/S 3"

1 ABD COMBINE PAD 5" X 9"

1 CPR FILTERSHIELD 77-100

1 BAGGED COMP MISC

1 BUFF EYEWASH 1oz

1 SCISSOR BDGE 4" RED PLS HDL

2 PR LRG NITRILE GLVES ZIP BAG

2 1" X 3" PLASTIC BANDS 16/BAG

2 TAPE ADHESIVE 1/2 X 2.5 125133

1 ADH BNDG PLASTIC EX-LG 4"X 2"

1 TRI BNDG NON WOVEN 40"X40"X56"

1 COLD PACK UNIT 4"X6" BULK

1 GAUZE PADS 2"X2" 12PLY

1 EYE PADS STD OVAL STERILE

4 GAUZE PADS 3"X3" 12PLY

3 WOVEN FINGERTIP BANDAGE 2"

2 WOVEN KNUCKLE BANDAGE

4068
SF00001232 Kit Contents

1 1X3 PLASTIC 100/BOX
1 TWEEZER PLASTICS 4"
1 FIRST AID GUIDE ASHI
3 GAUZE CLEAN-WRAP BDGE N/S 2"
2 GAUZE CLEAN-WRAP BDGE N/S 3"
1 ABD COMBINE PAD 5" X 9"
1 CO-FLEX BANDAGE 2"X 5YDS TAN
1 CPR FILTERSHIELD 77-100
2 BAGGED COMP MISC
1 1OZ. EYEWASH
1 SCISSOR BDGE 4" RED PLS HDL
1 LABEL NORTH CONTENTS 8X8 ID B
1 LABEL RAPID PICS 24U/50P
2 PR LRG NITRILE GLVES ZIP BAG
2 TAPE ADHESIVE 1/2 X 2.5 125133
2 ADH BNDG PLASTIC EX-LG 4"X 2"
1 KIT PP 24 UNIT FA
1 BAG ZIPPER POLY 6 X 6 2 MIL

4081
Z019702-0002L Kit Contents

1 TWEEZER PLASTICS 4"
1 FIRST AID GUIDE ASHI
2 GAUZE CLEAN-WRAP BDGE N/S 2"
1 GAUZE CLEAN-WRAP BDGE N/S 3"
1 ABD COMBINE PAD 5" X 9"
1 CPR FILTERSHIELD 77-100
1 BAGGED COMP MISC
1 1 OZ, BUFF EYEWASH
1 SCISSOR BDGE 4" RED PLS HDL
1 2 PR LRG NITRILE GLVES ZIP BAG
2 1" X 3" PLASTIC BANDS 16/BAG
2 TAPE ADHESIVE 1/2 X 2.5 125133
1 ADH BNDG PLASTIC EX-LG 4"X 2"
1 KIT, PP 16 UNIT FA
1 LBL 25P CVR NORTH ID B
1 TRI BNDG NON WOVEN 40"X40"X56"
1 COLD PACK UNIT 4"X6" BULK
1 GAUZE PADS 2"X2" 12PLY
1 EYE PADS STD OVAL STERILE
4 GAUZE PADS 3"X3" 12PLY
3 WOVEN FINGERTIP BANDAGE 2"
2 WOVEN KNUCKLE BANDAGE

4082
Z019704-0003L Kit Contents

1 1X3 PLASTIC 100/BOX
1 TWEEZER PLASTICS 4"
1 FIRST AID GUIDE ASHI
3 GAUZE CLEAN-WRAP BDGE N/S 2"
2 GAUZE CLEAN-WRAP BDGE N/S 3"
1 ABD COMBINE PAD 5" X 9"
1 CO-FLEX BANDAGE 2"X 5YDS TAN
1 CPR FILTERSHIELD 77-100
2 BAGGED COMP MISC
1 1 OZ. EYEWASH
1 SCISSOR BDGE 4" RED PLS HDL
1 2 PR LRG NITRILE GLVES ZIP BAG
2 TAPE ADHESIVE 1/2 X 2.5 125133
2 ADH BNDG PLASTIC EX-LG 4"X 2"
1 KIT PP 24 UNIT FA
1 LBL 50P CVR NORTH ID B
1 TRI BNDG NON WOVEN 40"X40"X56"
2 COLD PACK UNIT 4"X6" BULK
8 GAUZE PADS 2"X2" 12PLY
2 EYE PADS STD OVAL STERILE
4 GAUZE PADS 3"X3" 12PLY
4 WOVEN FINGERTIP BANDAGE 2"
3 WOVEN KNUCKLE BANDAGE

4083
019702-0002L Kit Contents

1 TWEEZER PLASTICS 4"
1 FIRST AID GUIDE ASHI
2 GAUZE CLEAN-WRAP BDGE N/S 2"
1 GAUZE CLEAN-WRAP BDGE N/S 3"
1 ABD COMBINE PAD 5" X 9"
1 CPR FILTERSHIELD 77-100
1 BAGGED COMP MISC
1 1 OZ. EYEWASH
1 SCISSOR BDGE 4" RED PLS HDL
1 2 PR LRG NITRILE GLVES ZIP BAG
2 1" X 3" PLASTIC BANDS 16/BAG
2 TAPE ADHESIVE 1/2 X 2.5 125133
1 ADH BNDG PLASTIC EX-LG 4"X 2"
1 KIT, PP 16 UNIT FA
1 LBL 25P CVR NORTH ID B
1 TRI BNDG NON WOVEN 40"X40"X56"
1 COLD PACK UNIT 4"X6" BULK
1 GAUZE PADS 2"X2" 12PLY
1 EYE PADS STD OVAL STERILE
4 GAUZE PADS 3"X3" 12PLY
3 WOVEN FINGERTIP BANDAGE 2"
2 WOVEN KNUCKLE BANDAGE

4084
019703-0002L Kit Contents


1 GAUZE PADS, 3" X 3", 4 PER
1 TWEEZER PLASTICS 4"
1 FIRST AID GUIDE ASHI
2 GAUZE CLEAN-WRAP BDGE N/S 2"
1 GAUZE CLEAN-WRAP BDGE N/S 3"
1 ABD COMBINE PAD 5" X 9"
1 CPR FILTERSHIELD 77-100
1 BAGGED COMP MISC
1 1 OZ.EYEWASH
1 SCISSOR BDGE 4" RED PLS HDL
1 2 PR LRG NITRILE GLVES ZIP BAG
2 1" X 3" PLASTIC BANDS 16/BAG
2 TAPE ADHESIVE 1/2 X 2.5 125133
1 ADH BNDG PLASTIC EX-LG 4"X 2"
1 KIT STL 16 UN (HORIZONTAL)

1 LBL CONTENTS ANSI Z308.1-2009 REV B
1 LBL 25P CVR NORTH ID B

1 TRI BNDG NON WOVEN 40"X40"X56"
1 COLD PACK UNIT 4"X6" BULK
4 GAUZE PADS 2"X2" 12PLY
1 EYE PADS STD OVAL STERILE
3 WOVEN FINGERTIP BANDAGE 2"
2 WOVEN KNUCKLE BANDAGE

4085
019703-4503 Kit Contents

1 TWEEZER PLASTICS 4"
1 FIRST AID GUIDE ASHI
2 GAUZE CLEAN-WRAP BDGE N/S 2"
1 GAUZE CLEAN-WRAP BDGE N/S 3"
1 ABD COMBINE PAD 5" X 9"
1 CPR FILTERSHIELD 77-100
1 BAGGED COMP MISC
1 1 OZ.EYEWASH
1 SCISSOR BDGE 4" RED PLS HDL
1 2 PR LRG NITRILE GLVES ZIP BAG
2 TAPE ADHESIVE 1/2 X 2.5 125133
1 ADH BNDG PLASTIC EX-LG 4"X 2"
1 KIT STL 16 UN (HORIZONTAL)
1 1 LBL 25P CVR NORTH ID B
1 TRI BNDG NON WOVEN 40"X40"X56"
1 COLD PACK UNIT 4"X6" BULK
4 GAUZE PADS 2"X2" 12PLY
1 EYE PADS STD OVAL STERILE
1 GAUZE PADS 3"X3" 12PLY
30 PLASTIC BANDAGE 1" X 3"
3 WOVEN FINGERTIP BANDAGE 2"
2 WOVEN KNUCKLE BANDAGE

4086
019704-0003L Kit Contents

1 1X3 PLASTIC 100/BOX
1 GAUZE PADS, 3" X 3", 4 PER
1 TWEEZER PLASTICS 4"
1 FIRST AID GUIDE ASHI
3 GAUZE CLEAN-WRAP BDGE N/S 2"
2 GAUZE CLEAN-WRAP BDGE N/S 3"
1 ABD COMBINE PAD 5" X 9"
1 CO-FLEX BANDAGE 2"X 5YDS TAN
1 CPR FILTERSHIELD 77-100
2 BAGGED COMP MISC
1 1 OZ. EYEWASH
1 SCISSOR BDGE 4" RED PLS HDL
1 LABEL NORTH CONTENTS 8X8 ID B
1 2 PR LRG NITRILE GLVES ZIP BAG
2 TAPE ADHESIVE 1/2 X 2.5 125133
2 ADH BNDG PLASTIC EX-LG 4"X 2"
1 KIT PP 24 UNIT FA
1 LBL CONTENTS ANSI Z308.1-2009 REV B
1 LBL 50P CVR NORTH ID B
1 TRI BNDG NON WOVEN 40"X40"X56"
2 COLD PACK UNIT 4"X6" BULK
10 GAUZE PADS 2"X2" 12PLY
2 EYE PADS STD OVAL STERILE
4 WOVEN FINGERTIP BANDAGE 2"
3 WOVEN KNUCKLE BANDAGE

4087
019704-4504 Kit Contents

1 1X3 PLASTIC 100/BOX
1 TWEEZER PLASTICS 4"
1 FIRST AID GUIDE ASHI
3 GAUZE CLEAN-WRAP BDGE N/S 2"
2 GAUZE CLEAN-WRAP BDGE N/S 3"
1 ABD COMBINE PAD 5" X 9"
1 CO-FLEX BANDAGE 2"X 5YDS TAN
1 CPR FILTERSHIELD 77-100
2 BAGGED COMP MISC
1 1 OZ.EYEWASH
1 SCISSOR BDGE 4" RED PLS HDL
1 2 PR LRG NITRILE GLVES ZIP BAG
2 TAPE ADHESIVE 1/2 X 2.5 125133
2 ADH BNDG PLASTIC EX-LG 4"X 2"
1 KIT PP 24 UNIT FA
1 LBL 50P CVR NORTH ID B
1 TRI BNDG NON WOVEN 40"X40"X56"
2 COLD PACK UNIT 4"X6" BULK
10 GAUZE PADS 2"X2" 12PLY
2 EYE PADS STD OVAL STERILE
2 GAUZE PADS 3"X3" 12PLY
4 WOVEN FINGERTIP BANDAGE 2"
3 WOVEN KNUCKLE BANDAGE

4088
019705-4505 Kit Contents

1 1" X 3" PLAS 100/BOX
1 TWEEZER PLASTICS 4"
1 FIRST AID GUIDE ASHI
3 GAUZE CLEAN-WRAP BDGE N/S 2"
2 GAUZE CLEAN-WRAP BDGE N/S 3"
1 ABD COMBINE PAD 5" X 9"
1 CO-FLEX BANDAGE 2"X 5YDS TAN
1 CPR FILTERSHIELD 77-100
2 BAGGED COMP MISC
1 1 OZ.EYEWASH
1 SCISSOR BDGE 4" RED PLS HDL
1 2 PR LRG NITRILE GLVES ZIP BAG
2 TAPE ADHESIVE 1/2 X 2.5 125133
2 ADH BNDG PLASTIC EX-LG 4"X 2"
1 KIT STL 24 UN WHITE 01
1 LBL 50P CVR NORTH ID B
1 TRI BNDG NON WOVEN 40"X40"X56"
2 COLD PACK UNIT 4"X6" BULK
10 GAUZE PADS 2"X2" 12PLY
2 EYE PADS STD OVAL STERILE
2 GAUZE PADS 3"X3" 12PLY
4 WOVEN FINGERTIP BANDAGE 2"
3 WOVEN KNUCKLE BANDAGE

4089
Z019707-0004L Kit Contents

1 1X3 PLASTIC 100/BOX
1 WIRE SPLINT 1 PER
1 TWEEZER PLASTICS 4"
1 FIRST AID GUIDE ASHI
4 GAUZE CLEAN-WRAP BDGE N/S 2"
2 GAUZE CLEAN-WRAP BDGE N/S 3"
1 ABD COMBINE PAD 5" X 9"
1 GZE PADS STERILE 2"X 2" 10'S
1 CO-FLEX BANDAGE 2"X 5YDS TAN
1 CPR FILTERSHIELD 77-100
2 BAGGED COMP MISC
1 1 OZ. EYEWASH
1 SCISSOR BDGE 4" RED PLS HDL
1 5 PR LRG NITRILE GLVES ZIP BAG
3 TAPE ADHESIVE 1/2 X 2.5 125133
3 ADH BNDG PLASTIC EX-LG 4"X 2"
1 KIT STL 36 UN WHT 01 HOR SHELF
1 LBL 75P CVR NORTH ID B
1 BAG ZIPPER POLY 6 X 6 2 MIL
1 TRI BNDG NON WOVEN 40"X40"X56"
2 COLD PACK UNIT 4"X6" BULK
3 EYE PADS STD OVAL STERILE
10 GAUZE PADS 3"X3" 12PLY
8 WOVEN FINGERTIP BANDAGE 2"
6 WOVEN KNUCKLE BANDAGE

4090
019706-0004L Kit Contents

1 1X3 PLASTIC 100/BOX
1 WIRE SPLINT 1 PER
1 TWEEZER PLASTICS 4"
1 FIRST AID GUIDE ASHI
4 GAUZE CLEAN-WRAP BDGE N/S 2"
2 GAUZE CLEAN-WRAP BDGE N/S 3"
1 ABD COMBINE PAD 5" X 9"
1 GZE PADS STERILE 2"X 2" 10'S
1 CO-FLEX BANDAGE 2"X 5YDS TAN
1 CPR FILTERSHIELD 77-100
2 BAGGED COMP MISC
2 1 OZ. EYEWASH
1 SCISSOR BDGE 4" RED PLS HDL
1 5 PR LRG NITRILE GLVES ZIP BAG
3 TAPE ADHESIVE 1/2 X 2.5 125133
3 ADH BNDG PLASTIC EX-LG 4"X 2"
1 KIT 36 UNIT PLASTIC
1 LBL CONTENTS ANSI Z308.1-2009 REV B
1 LBL 75P CVR NORTH ID B
1 TRI BNDG NON WOVEN 40"X40"X56"
2 COLD PACK UNIT 4"X6" BULK
3 EYE PADS STD OVAL STERILE
10 GAUZE PADS 3"X3" 12PLY
8 WOVEN FINGERTIP BANDAGE 2"
6 WOVEN KNUCKLE BANDAGE

Eye Wash Package label

Eye Wash Label

First Aid Burn Cream
Principal Display Panel

First Aid Burn Cream

BZK
Principal Display Panel

BZK Antiseptic Wipe

Aypanal
Principal Display Panel

Aypanal

Sting Relief
Principal Display Panel

Sting Relief

Neomycin Antibiotic Ointment
Principal Display Panel

Neomycin

4056 Kit Label
Z01985 Kit Label

4056 KIT

4068 Kit Label
SF00001232

4068 LABEL

4081 Kit Label
Z019702-0002L

4081/4023 kit

4082 Kit Label
Z019704-0003L

4025/4082 kit

4083 Kit Label
019702-0002L

4026/4083 kit

4084 Kit Label
019703-0002L

4027/4084 kit

4085 Kit Lael
019703-4503

4028/4085 kit

4086 Kit Label
019704-0003L

4029/4086 kit

4087 Kit Label
019704-4504

4030/4087 kit

4088 Kit Label
019705-4505

4031/4088 Kit

4089 Kit Label
Z019707-0004L

4040/4089 kit

4090 Kit Label
019706-0004L

4041/4090 kit

4056 FIRST AID KIT 
4056 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4056
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4056-011 in 1 KIT; Type 0: Not a Combination Product10/18/201810/18/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 30 mL
Part 23 PACKET
Part 36 POUCH 2.4 mL
Part 410 PACKET 9 g
Part 510 PACKET 9 g
Part 610 PACKET 14 mL
Part 1 of 6
EYESALINE EMERGENCY EYEWASH 
purified water liquid
Product Information
Item Code (Source)NDC:0498-0100
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER98.6 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0100-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01812/18/201801/08/2024
Part 2 of 6
AYPANAL NON-ASPIRIN 
acetaminophen tablet
Product Information
Item Code (Source)NDC:0498-2001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code circle;U
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-2001-012 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/10/201201/08/2024
Part 3 of 6
STING RELIEF PAD 
ethyl alcohol, lidocaine swab
Product Information
Item Code (Source)NDC:0498-0733
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.5 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
MENTHOL (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.4 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/23/201701/08/2024
Part 4 of 6
FIRST AID BURN 
benzalkonium chloride, lidocaine hydrochloride cream
Product Information
Item Code (Source)NDC:0498-0903
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/20/201701/08/2024
Part 5 of 6
NEOMYCIN 
antibiotic ointment
Product Information
Item Code (Source)NDC:0498-0730
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0730-010.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/31/2010
Part 6 of 6
ANTISEPTIC TOWELETTE 
benzalkonium chloride liquid
Product Information
Item Code (Source)NDC:0498-0501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11.4 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/21/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/18/201810/18/2019
4068 FIRST AID KIT 
4068 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4068
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4068-011 in 1 KIT; Type 0: Not a Combination Product10/18/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 30 mL
Part 26 PACKET 12 
Part 312 POUCH 4.8 mL
Part 420 PACKET 18 g
Part 520 PACKET 18 g
Part 620 PACKET 28 mL
Part 1 of 6
EYESALINE EMERGENCY EYEWASH 
purified water liquid
Product Information
Item Code (Source)NDC:0498-0100
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER98.6 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0100-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01812/18/2018
Part 2 of 6
AYPANAL NON-ASPIRIN 
acetaminophen tablet
Product Information
Item Code (Source)NDC:0498-2001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code circle;U
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-2001-012 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/10/2012
Part 3 of 6
STING RELIEF PAD 
ethyl alcohol, lidocaine swab
Product Information
Item Code (Source)NDC:0498-0733
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.5 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
MENTHOL (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.4 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/23/2017
Part 4 of 6
FIRST AID BURN 
benzalkonium chloride, lidocaine hydrochloride cream
Product Information
Item Code (Source)NDC:0498-0903
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/20/2017
Part 5 of 6
NEOMYCIN 
antibiotic ointment
Product Information
Item Code (Source)NDC:0498-0730
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0730-010.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/31/2010
Part 6 of 6
ANTISEPTIC TOWELETTE 
benzalkonium chloride liquid
Product Information
Item Code (Source)NDC:0498-0501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11.4 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/21/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/18/2018
4088 FIRST AID KIT 
4088 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4088
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4088-011 in 1 KIT; Type 0: Not a Combination Product10/18/201810/18/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 30 mL
Part 26 PACKET 12 
Part 312 POUCH 4.8 mL
Part 420 PACKET 18 g
Part 520 PACKET 18 g
Part 620 PACKET 28 mL
Part 1 of 6
EYESALINE EMERGENCY EYEWASH 
purified water liquid
Product Information
Item Code (Source)NDC:0498-0100
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER98.6 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0100-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01812/18/2018
Part 2 of 6
AYPANAL NON-ASPIRIN 
acetaminophen tablet
Product Information
Item Code (Source)NDC:0498-2001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code circle;U
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-2001-012 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/10/2012
Part 3 of 6
STING RELIEF PAD 
ethyl alcohol, lidocaine swab
Product Information
Item Code (Source)NDC:0498-0733
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.5 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
MENTHOL (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.4 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/23/2017
Part 4 of 6
FIRST AID BURN 
benzalkonium chloride, lidocaine hydrochloride cream
Product Information
Item Code (Source)NDC:0498-0903
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/20/2017
Part 5 of 6
NEOMYCIN 
antibiotic ointment
Product Information
Item Code (Source)NDC:0498-0730
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0730-010.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/31/2010
Part 6 of 6
ANTISEPTIC TOWELETTE 
benzalkonium chloride liquid
Product Information
Item Code (Source)NDC:0498-0501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11.4 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/21/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/18/201810/18/2019
4089 FIRST AID KIT 
4089 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4089
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4089-011 in 1 KIT; Type 0: Not a Combination Product10/18/201810/18/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 BOTTLE 60 mL
Part 26 PACKET 12 
Part 312 POUCH 4.8 mL
Part 420 PACKET 18 g
Part 520 PACKET 18 g
Part 620 PACKET 28 mL
Part 1 of 6
EYESALINE EMERGENCY EYEWASH 
purified water liquid
Product Information
Item Code (Source)NDC:0498-0100
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER98.6 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0100-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01812/18/2018
Part 2 of 6
AYPANAL NON-ASPIRIN 
acetaminophen tablet
Product Information
Item Code (Source)NDC:0498-2001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code circle;U
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-2001-012 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/10/2012
Part 3 of 6
STING RELIEF PAD 
ethyl alcohol, lidocaine swab
Product Information
Item Code (Source)NDC:0498-0733
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.5 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
MENTHOL (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.4 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/23/2017
Part 4 of 6
FIRST AID BURN 
benzalkonium chloride, lidocaine hydrochloride cream
Product Information
Item Code (Source)NDC:0498-0903
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/20/2017
Part 5 of 6
NEOMYCIN 
antibiotic ointment
Product Information
Item Code (Source)NDC:0498-0730
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0730-010.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/31/2010
Part 6 of 6
ANTISEPTIC TOWELETTE 
benzalkonium chloride liquid
Product Information
Item Code (Source)NDC:0498-0501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11.4 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/21/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/18/201810/18/2019
4081 FIRST AID KIT 
4081 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4081
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4081-011 in 1 KIT; Type 0: Not a Combination Product10/18/201810/18/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 110 PACKET 9 g
Part 21 BOTTLE 30 mL
Part 310 PACKET 9 g
Part 410 PACKET 14 mL
Part 53 PACKET
Part 66 POUCH 2.4 mL
Part 1 of 6
FIRST AID BURN 
benzalkonium chloride, lidocaine hydrochloride cream
Product Information
Item Code (Source)NDC:0498-0903
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID (UNII: 4ELV7Z65AP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/20/2017
Part 2 of 6
EYESALINE EMERGENCY EYEWASH 
purified water liquid
Product Information
Item Code (Source)NDC:0498-0100
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER98.6 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0100-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/18/2018
Part 3 of 6
NEOMYCIN 
antibiotic ointment
Product Information
Item Code (Source)NDC:0498-0730
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0730-010.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/31/2010
Part 4 of 6
ANTISEPTIC TOWELETTE 
benzalkonium chloride liquid
Product Information
Item Code (Source)NDC:0498-0501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11.4 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/21/2017
Part 5 of 6
AYPANAL NON-ASPIRIN 
acetaminophen tablet
Product Information
Item Code (Source)NDC:0498-2001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code circle;U
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-2001-012 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/10/2012
Part 6 of 6
STING RELIEF PAD 
ethyl alcohol, lidocaine swab
Product Information
Item Code (Source)NDC:0498-0733
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.5 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
MENTHOL (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.4 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/23/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/18/201810/18/2019
4090 FIRST AID KIT 
4090 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4090
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4090-011 in 1 KIT; Type 0: Not a Combination Product10/18/201810/18/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 BOTTLE 60 mL
Part 26 PACKET 12 
Part 312 POUCH 4.8 mL
Part 420 PACKET 18 g
Part 520 PACKET 18 g
Part 620 PACKET 28 mL
Part 1 of 6
EYESALINE EMERGENCY EYEWASH 
purified water liquid
Product Information
Item Code (Source)NDC:0498-0100
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER98.6 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0100-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01812/18/2018
Part 2 of 6
AYPANAL NON-ASPIRIN 
acetaminophen tablet
Product Information
Item Code (Source)NDC:0498-2001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code circle;U
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-2001-012 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/10/2012
Part 3 of 6
STING RELIEF PAD 
ethyl alcohol, lidocaine swab
Product Information
Item Code (Source)NDC:0498-0733
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.5 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
MENTHOL (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.4 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/23/2017
Part 4 of 6
FIRST AID BURN 
benzalkonium chloride, lidocaine hydrochloride cream
Product Information
Item Code (Source)NDC:0498-0903
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/20/2017
Part 5 of 6
NEOMYCIN 
antibiotic ointment
Product Information
Item Code (Source)NDC:0498-0730
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0730-010.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/31/2010
Part 6 of 6
ANTISEPTIC TOWELETTE 
benzalkonium chloride liquid
Product Information
Item Code (Source)NDC:0498-0501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11.4 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/21/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/18/201810/18/2019
4083 FIRST AID KIT 
4083 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4083
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4083-011 in 1 KIT; Type 0: Not a Combination Product10/18/201810/18/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 30 mL
Part 23 PACKET
Part 36 POUCH 2.4 mL
Part 410 PACKET 9 g
Part 510 PACKET 9 g
Part 610 PACKET 14 mL
Part 1 of 6
EYESALINE EMERGENCY EYEWASH 
purified water liquid
Product Information
Item Code (Source)NDC:0498-0100
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER98.6 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0100-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01812/18/2018
Part 2 of 6
AYPANAL NON-ASPIRIN 
acetaminophen tablet
Product Information
Item Code (Source)NDC:0498-2001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code circle;U
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-2001-012 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/10/2012
Part 3 of 6
STING RELIEF PAD 
ethyl alcohol, lidocaine swab
Product Information
Item Code (Source)NDC:0498-0733
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.5 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
MENTHOL (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.4 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/23/2017
Part 4 of 6
FIRST AID BURN 
benzalkonium chloride, lidocaine hydrochloride cream
Product Information
Item Code (Source)NDC:0498-0903
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/20/2017
Part 5 of 6
NEOMYCIN 
antibiotic ointment
Product Information
Item Code (Source)NDC:0498-0730
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0730-010.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/31/2010
Part 6 of 6
ANTISEPTIC TOWELETTE 
benzalkonium chloride liquid
Product Information
Item Code (Source)NDC:0498-0501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11.4 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/21/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/18/201810/18/2019
4087 FIRST AID KIT 
4087 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4087
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4087-011 in 1 KIT; Type 0: Not a Combination Product10/18/201810/18/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 16 PACKET 12 
Part 212 POUCH 4.8 mL
Part 320 PACKET 18 g
Part 420 PACKET 18 g
Part 520 PACKET 28 mL
Part 61 BOTTLE 30 mL
Part 1 of 6
AYPANAL NON-ASPIRIN 
acetaminophen tablet
Product Information
Item Code (Source)NDC:0498-2001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code circle;U
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-2001-012 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/10/2012
Part 2 of 6
STING RELIEF PAD 
ethyl alcohol, lidocaine swab
Product Information
Item Code (Source)NDC:0498-0733
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.5 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
MENTHOL (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.4 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/23/2017
Part 3 of 6
FIRST AID BURN 
benzalkonium chloride, lidocaine hydrochloride cream
Product Information
Item Code (Source)NDC:0498-0903
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PEG-100 STEARATE (UNII: YD01N1999R)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/20/2017
Part 4 of 6
NEOMYCIN 
antibiotic ointment
Product Information
Item Code (Source)NDC:0498-0730
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0730-010.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/31/2010
Part 5 of 6
ANTISEPTIC TOWELETTE 
benzalkonium chloride liquid
Product Information
Item Code (Source)NDC:0498-0501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11.4 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/21/2017
Part 6 of 6
EYESALINE EMERGENCY EYEWASH 
purified water liquid
Product Information
Item Code (Source)NDC:0498-0100
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER98.6 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0100-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01812/18/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/18/201810/18/2019
4082 FIRST AID KIT 
4082 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4082
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4082-011 in 1 KIT; Type 0: Not a Combination Product10/18/201810/18/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 30 mL
Part 26 PACKET 12 
Part 312 POUCH 4.8 mL
Part 420 PACKET 18 g
Part 520 PACKET 18 g
Part 620 PACKET 28 mL
Part 1 of 6
EYESALINE EMERGENCY EYEWASH 
purified water liquid
Product Information
Item Code (Source)NDC:0498-0100
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER98.6 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0100-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01812/18/2018
Part 2 of 6
AYPANAL NON-ASPIRIN 
acetaminophen tablet
Product Information
Item Code (Source)NDC:0498-2001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code circle;U
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-2001-012 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/10/2012
Part 3 of 6
STING RELIEF PAD 
ethyl alcohol, lidocaine swab
Product Information
Item Code (Source)NDC:0498-0733
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.5 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
MENTHOL (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.4 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/23/2017
Part 4 of 6
FIRST AID BURN 
benzalkonium chloride, lidocaine hydrochloride cream
Product Information
Item Code (Source)NDC:0498-0903
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/20/2017
Part 5 of 6
NEOMYCIN 
antibiotic ointment
Product Information
Item Code (Source)NDC:0498-0730
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0730-010.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/31/2010
Part 6 of 6
ANTISEPTIC TOWELETTE 
benzalkonium chloride liquid
Product Information
Item Code (Source)NDC:0498-0501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11.4 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/21/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/18/201810/18/2019
4084 FIRST AID KIT 
4084 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4084
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4084-011 in 1 KIT; Type 0: Not a Combination Product10/18/201810/18/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 30 mL
Part 23 PACKET
Part 36 POUCH 2.4 mL
Part 410 PACKET 9 g
Part 510 PACKET 9 g
Part 610 PACKET 14 mL
Part 1 of 6
EYESALINE EMERGENCY EYEWASH 
purified water liquid
Product Information
Item Code (Source)NDC:0498-0100
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER98.6 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0100-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01812/18/2018
Part 2 of 6
AYPANAL NON-ASPIRIN 
acetaminophen tablet
Product Information
Item Code (Source)NDC:0498-2001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code circle;U
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-2001-012 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/10/2012
Part 3 of 6
STING RELIEF PAD 
ethyl alcohol, lidocaine swab
Product Information
Item Code (Source)NDC:0498-0733
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.5 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
MENTHOL (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.4 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/23/2017
Part 4 of 6
FIRST AID BURN 
benzalkonium chloride, lidocaine hydrochloride cream
Product Information
Item Code (Source)NDC:0498-0903
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/20/2017
Part 5 of 6
NEOMYCIN 
antibiotic ointment
Product Information
Item Code (Source)NDC:0498-0730
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0730-010.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/31/2010
Part 6 of 6
ANTISEPTIC TOWELETTE 
benzalkonium chloride liquid
Product Information
Item Code (Source)NDC:0498-0501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11.4 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/21/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/18/201810/18/2019
4085 FIRST AID KIT 
4085 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4085
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4085-011 in 1 KIT; Type 0: Not a Combination Product10/18/201810/18/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 30 mL
Part 23 PACKET
Part 36 POUCH 2.4 mL
Part 410 PACKET 9 g
Part 510 PACKET 9 g
Part 610 PACKET 14 mL
Part 1 of 6
EYESALINE EMERGENCY EYEWASH 
purified water liquid
Product Information
Item Code (Source)NDC:0498-0100
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER98.6 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0100-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01812/18/2018
Part 2 of 6
AYPANAL NON-ASPIRIN 
acetaminophen tablet
Product Information
Item Code (Source)NDC:0498-2001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code circle;U
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-2001-012 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/10/2012
Part 3 of 6
STING RELIEF PAD 
ethyl alcohol, lidocaine swab
Product Information
Item Code (Source)NDC:0498-0733
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.5 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
MENTHOL (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.4 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/23/2017
Part 4 of 6
FIRST AID BURN 
benzalkonium chloride, lidocaine hydrochloride cream
Product Information
Item Code (Source)NDC:0498-0903
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/20/2017
Part 5 of 6
NEOMYCIN 
antibiotic ointment
Product Information
Item Code (Source)NDC:0498-0730
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0730-010.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/31/2010
Part 6 of 6
ANTISEPTIC TOWELETTE 
benzalkonium chloride liquid
Product Information
Item Code (Source)NDC:0498-0501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11.4 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/21/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/18/201810/18/2019
4086 FIRST AID KIT 
4086 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4086
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4086-011 in 1 KIT; Type 0: Not a Combination Product10/18/201810/18/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 30 mL
Part 26 PACKET 12 
Part 312 POUCH 4.8 mL
Part 420 PACKET 18 g
Part 520 PACKET 18 g
Part 620 PACKET 28 mL
Part 1 of 6
EYESALINE EMERGENCY EYEWASH 
purified water liquid
Product Information
Item Code (Source)NDC:0498-0100
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER98.6 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0100-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01812/18/2018
Part 2 of 6
AYPANAL NON-ASPIRIN 
acetaminophen tablet
Product Information
Item Code (Source)NDC:0498-2001
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code circle;U
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-2001-012 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/10/2012
Part 3 of 6
STING RELIEF PAD 
ethyl alcohol, lidocaine swab
Product Information
Item Code (Source)NDC:0498-0733
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.5 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
MENTHOL (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.4 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/23/2017
Part 4 of 6
FIRST AID BURN 
benzalkonium chloride, lidocaine hydrochloride cream
Product Information
Item Code (Source)NDC:0498-0903
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/20/2017
Part 5 of 6
NEOMYCIN 
antibiotic ointment
Product Information
Item Code (Source)NDC:0498-0730
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0730-010.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/31/2010
Part 6 of 6
ANTISEPTIC TOWELETTE 
benzalkonium chloride liquid
Product Information
Item Code (Source)NDC:0498-0501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11.4 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/21/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/18/201810/18/2019
Labeler - Honeywell Safety Products USA, INC (118768815)

Revised: 1/2024
Document Id: 0f8c8915-1eef-44a5-e063-6394a90a499a
Set id: 7f384da5-0ea4-812d-e053-2a91aa0a4803
Version: 14
Effective Time: 20240122
 
Honeywell Safety Products USA, INC