4400 FIRST AID KIT- 4400 first aid kit 
4264 FIRST AID KIT- 4264 first aid kit 
4266 FIRST AID KIT- 4266 first aid kit 
4265 FIRST AID KIT- 4265 first aid kit 
4310 FIRST AID KIT- 4310 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.

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0498-4264, 4265, 4266, 4310, 4400:First Aid Kit (Neomycin, EW, alcohol wipes, Burn Sray, Antiseptic Spray, Hand Sanitizer, aypanal- FAK100CAB-CLSB, FAK150CAB-CLSB, FAK200CAB-CLSB, SF00004442, FAKREF100-B)

Eyesaline
Active ingredient

Sterile Water 99%

Eyesaline
Purpose

Eyewash

Eyesaline
Uses

  • for flushing the eye to remove loose foreign material, air pollutants or chlorinated water

Eyesaline
Warnings

For external use only-

Obtain immediate medical treatment for all open wounds in or near 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 eye
  • condition worsens or persists


Keep out of reach of children


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

Eyesaline
Directions

  • remove contacts before using
  • twist top to remove
  • flush the affected area as needed
  • control rate of flow by pressure on the bottle
  • if necessary, continue flushing with emergency eyewash or shower

Eyesaline
Inactive ingredients

sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

Eyesaline
Questions

1-800-430-5490 Honeywell Sadety Products USA, Inc. Smithfield, RI 02917

Alcohol Wipe
Active ingredient

Isopropyl alcohol 70%

Alcohol Wipe
Purpose

First aid antiseptic

Alcohol Wipe
Uses

  • first aid to help prevent infection in minor cuts, scrapes, and burns

Alcohol Wipe
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 burn


When using this product

  • do not use longer than one week unless directed by a doctor


Stop use and consult a doctor

  • if condition persists or gets worse

Keep out of reach of children

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

Alcohol Wipe
Directions

  • clean the affected area
  • apply wipe to affected area 1 to 3 times daily
  • may be covered with a sterile bandage
  • discard wipe after single use

Alcohol Wipe
Other information

store at room temperature 15 0 to 25 0 C (59 0 to 77 0F)

Alcohol Wipe
Inactive ingredient

water

Alcohol Wipe
Questions

1-800-430-5490

Aypanal
Active ingredient

Acetaminophen 325 mg

Aypanal
Purpose

Pain reliever/ fever reducer

Aypanaly
Uses

  • temporarily relieves minor aches and pains due to the common cold and headache - temporarily reduces fever

Keep out of reach of children.

Keep out of reach of children.

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 more than 5 doses in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using this product:

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

  • skin reddening
  • blisters
  • rash
  • If a skin rash occurs, stop use and seek medical help right away.

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


Stop using and ask a doctor if

  • pain gets worse or lasts more than 10 days in adults
  • pain gets worse or lasts more than 5 days in children under 12 years
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur

If pregnant or breast-feeding

If pregnant or breast-feeding, ask a health professional before use.


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

do not take more than directed (see overdose warning)

​adults and children 12 years of age or older

  • take two tablets every 4-6 hours while symptoms last
  • do not take more than 12 tablets in 24 hours

children 6 to under 12 years of age

  • take 1 tablet every 4-6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours

children under 6 years consult a doctor

Aypanal
Other information

  • store at room temperature 15 0 to 30 0 C (59 0 - 86 0 F)
  • 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

1-800-430-5490

Neomycin
Active ingredient

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

Neomycin
Purpose

First aid antibiotic

Neomycin
Uses

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

Do not use

  • in the eyes
  • over large areas of the body

Neomycin
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

  • a rash or other allergic reaction develops
  • you need to use longer than 1 week

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
Direction

  • clean the affected area
  • apply a small amount of the product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
  • may be covered with a sterile bandage

Neomycin
Other information


store at 15 0 to 25 0 C (59 0 to 77 0 F)

Neomycin
Inactive ingredient

petrolatum

Neomycin
Questions?

1-800-430-5490

Antiseptic Spray
Active ingredient

Benzalkonium chloride 0.13%

Antiseptic Spray
Purpose

First aid antiseptic

Antiseptic Spray
Uses

  • first aid to help prevent infection in minor cuts, scrapes and burns

Antiseptic Spray
Warnings

For external use only

Do not use

  • in or near the eyes
  • over large areas of the body

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product

  • do not use longer than one week unless directed by a doctor

Stop use and ask a doctor if

  • 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

Antiseptic Spray
Directions

  • clean the affected area
  • spray a small amount of this product on the area 1 to 3 times daily
  • may be covered with a sterile bandage
  • if bandaged, let dry first

Antiseptic Spray
Other information

  • shake well
  • store at room temperature 15 0-30 0 C (59 0 -86 0 F)

Antiseptic Spray
Inactive ingredients

diazolidinyl urea, edetate disodium, glycerin, hypromellose, methylparaben, octoxynol 9, propylene glycol, propylparaben, trolamine, water

Antiseptic Spray
Questions

1-800-430-5490

Burn Spray
Active ingredient

Benzethonium chloride 0.2% w/w

Benzocaine 10% w/w

Menthol 0.33% w/w

Burn Spray
Purpose

Benzethonium chloride 0.2% w/w

Benzocaine 10% w/w

Menthol 0.33% w/w

Burn Spray
Uses

for the temporary relief of pain and itching and helps protect against infection in:

  • minor cuts and scrapes
  • burns
  • sunburn
  • insect bites
  • minor skin irritations

Burn Spray
Warnings

For external use only

Flammable

  • keep away from fire or flame
  • contents under pressure
  • do not puncture or incinerate container
  • do not expose to temperatures above 120 0 F

Do not use

  • in or near the eyes or other mucous membranes
  • in case of serious burns
  • in case of deep or puncture wounds
  • for prolonged period of time
  • on large portion of the body

Stop use and ask a doctor if

  • condition worsens or symptoms persist for more than 7 days
  • condition clears up and recurs within a few days
  • redness, swelling, or irritation occurs

Keep out of the reach of children

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

Burn Spray
Directions

  • clean the affected area
  • shake can well before using
  • hold 4 - 6 inches from surface and spray area until wet
  • may be covered with a sterile bandage, if bandaged let dry first
  • for adult institutional use only
  • not intended for use on children

Burn Spray
Other information

  • avoid inhaling
  • use only as directed
  • intentional misuse by deliberately concentrating or inhaling the contents may be harmful or fatal

Burn Spray
Inactive ingredients

dipropylene glycol, isobutane, n-butane, propane

Hans Sanitizer
Active ingredient

Ethyl alcohol 62%

Hand Santizer
Purpose

Antiseptic handwash

Hand Sanitizer
Uses

  • for hand washing to decrease bacteria on skin
  • recommended for repeated use

Hand Sanitizer
Warnings

For external use only

Flammable, keep away from fire or flame

When using this product

  • do not use in the eyes
  • discontinue use if irritation and redness develops. If condition persists for more than 72 hours consult a doctor.

Keep out of reach of children

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

Hand Sanitizer
Directions

  • wet hands thoroughly with product and allow to dry without wiping

Hand Sanitizer
Other information

store at 15 0 to 25 0 C (59 0 to 77 0 F)

Hand Sanitizer
Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, dl-alpha tocopheryl acetate, fragrance, PEG-60 almond glycerides, propylene glycol, purified water, triisopropanolamine

Hand Sanitizer
Questions or Comments?

1-800-275-3433 info@waterjel.com www.waterjel.com

4265
FAK150CAB-CLSB kit contents

1 1X3 PLASTIC 100/BOX

1 FINGERTIP "T" WOVEN 40/BOX

1 SWIFT KNUCKLE 40/BX

3 NEOMYCIN ANTIBIOTIC 10 PER

2 EYE DRESS PKT W/4 ADH STRIPS

1 TOURNIQUET, 1 PER

1 WIRE SPLINT 1 PER

1 ADH BAND, EXTRA LARGE, 6 PER

1 ALCOHOL PREP PADS 10P

1 ADHESIVE TAPE W/P 1/2"X 5 YD

2 O/H PUMP ANTISEPTIC 2 OZ ID F

2 O/H PUMP BURN RELIEF 2 OZ ID G

1 FIRST AID GUIDE ASHI

2 TAPE ADHESIVE 1"X 5 YD PLSTC

20 HAND SANITIZER 0.9G WJ BULK

6 GAUZE CLEAN-WRAP BDGE N/S 2"

6 GAUZE CLEAN-WRAP BDGE N/S 4"

4 BLOODSTOPPER

2 NON-ADHERENT PADS 2"X3" 10'S

1 GZE PADS STERILE 2"X 2" 10'S

1 GZE PADS STERILE 3"X 3" 25'S

3 ELASTIC BANDAGE 3" X 4.5YD

1 CPR FILTERSHIELD 77-100

1 AYPANAL NON-ASP IND 2/ENV 100

1 4OZ BFS EYEWASH TRILINGUAL BOTTLE

1 SCISSOR BDGE 4" RED PLS HDL

1 KIT TWEEZER 3 1/2" SLANTED

1 LBL STOCK 6-3/8"X4"

1 LBL STOCK 4"X2-7/8"

8 PR LRG NITRILE GLVES ZIP BAG

2 WATER-JEL BURN DRESSING 4 X 4

1 KIT STL LARGE FA CABINET

1 LBL CONTENTS ANSI 2015 CL B

1 LBL CAB CVR ANSI 2015 CL B

2 TRI BNDG NON WOVEN 40"X40"X56"

3 COLD PACK UNIT 4"X6" BULK

4266
FAK200CAB-CLSB kit contents

1 1X3 PLASTIC 100/BOX

1 FINGERTIP "T" WOVEN 40/BOX

1 SWIFT KNUCKLE 40/BX

3 NEOMYCIN ANTIBIOTIC 10 PER

3 EYE DRESS PKT W/4 ADH STRIPS

1 TOURNIQUET, 1 PER

1 WIRE SPLINT 1 PER

1 ADH BAND, EXTRA LARGE, 6 PER

2 ALCOHOL PREP PADS 10P

2 ADHESIVE TAPE W/P 1/2"X 5 YD

2 O/H PUMP ANTISEPTIC 2 OZ ID F

2 O/H PUMP BURN RELIEF 2 OZ ID G

1 FIRST AID GUIDE ASHI

2 TAPE ADHESIVE 1"X 5 YD PLSTC

30 HAND SANITIZER 0.9G WJ BULK

8 GAUZE CLEAN-WRAP BDGE N/S 2"

8 GAUZE CLEAN-WRAP BDGE N/S 4"

4 BLOODSTOPPER

2 NON-ADHERENT PADS 2"X3" 10'S

2 GZE PADS STERILE 2"X 2" 10'S

2 GZE PADS STERILE 3"X 3" 25'S

4 ELASTIC BANDAGE 3" X 4.5YD

1 CPR FILTERSHIELD 77-100

2 AYPANAL NON-ASP IND 2/ENV 100

2 4OZ BFS EYEWASH TRILINGUAL BOTTLE

1 SCISSOR BDGE 4" RED PLS HDL

1 KIT TWEEZER 3 1/2" SLANTED

1 LBL STOCK 6-3/8"X4"

1 LBL STOCK 4"X2-7/8"

8 PR LRG NITRILE GLVES ZIP BAG

3 WATER-JEL BURN DRESSING 4 X 4

1 KIT STL DELUXE FA CABINET

1 POCKET FA CABINET LARGE

1 SHELF LG FA CABINET

1 LBL CONTENTS ANSI 2015 CL B

1 LBL CAB CVR ANSI 2015 CL B

8 CORNER STYROFOAM 3X3X3

3 TRI BNDG NON WOVEN 40"X40"X56"

4 COLD PACK UNIT 4"X6" BULK

4310
SF00004442 Kit Contents

1 1X3 PLASTIC 100/BOX

1 FINGERTIP "T" WOVEN 40/BOX

1 SWIFT KNUCKLE 40/BX

3 NEOMYCIN ANTIBIOTIC 10 PER

2 EYE DRESS PKT W/4 ADH STRIPS

1 TOURNIQUET, 1 PER

1 WIRE SPLINT 1 PER

1 ADH BAND, EXTRA LARGE, 6 PER

1 ALCOHOL PREP PADS 10P

1 O/H PUMP ANTISEPTIC 2 OZ ID F

1 O/H PUMP BURN RELIEF 2 OZ ID G

1 FIRST AID GUIDE ASHI

2 TAPE ADHESIVE 1"X 5 YD PLSTC

10 HAND SANITIZER 0.9G WJ BULK

4 GAUZE CLEAN-WRAP BDGE N/S 2"

4 GAUZE CLEAN-WRAP BDGE N/S 4"

4 BLOODSTOPPER

1 NON-ADHERENT PADS 2"X3" 10'S

1 GZE PADS STERILE 2"X 2" 10'S

1 GZE PADS STERILE 3"X 3" 25'S

1 ELASTIC BANDAGE 3" X 4.5YD

1 CPR FILTERSHIELD 77-100

1 AYPANAL NON-ASP IND 2/ENV 100

1 4OZ BFS EYEWASH TRILINGUAL BOTTLE

1 SCISSOR BDGE 4" RED PLS HDL

1 KIT TWEEZER 3 1/2" SLANTED

1 LBL STOCK 6-3/8"X4"

1 LBL STOCK 4"X2-7/8"

8 PR LRG NITRILE GLVES

2 WATER-JEL BURN DRESSING 4 X 4

1 KIT ST MED FA CABINET-SP SHELF

2 TRI BNDG NON WOVEN 40"X40"X56"

2 COLD PACK UNIT 4"X6" BULK

4400
FAKREF100-B Kit Contents

1 1X3 PLASTIC 100/BOX

1 FINGERTIP "T" WOVEN 40/BOX

1 SWIFT KNUCKLE 40/BX

1 HAND SANITIZER 10/PER

1 NEOMYCIN OINT 0.9 GM , UNTZD 25/BX

2 EYE DRESS PKT W/4 ADH STRIPS

1 TOURNIQUET

1 WIRE SPLINT 1 PER

1 ADH BAND, EXTRA LARGE, 6 PER

1 ALCOHOL PREP PADS 10P

1 O/H PUMP ANTISEPTIC 2 OZ ID F

1 O/H PUMP BURN RELIEF 2 OZ ID G

1 FIRST AID GUIDE ASHI

2 TAPE ADHESIVE 1"X 5 YD PLSTC

4 GAUZE CLEAN-WRAP BDGE N/S 2"

4 GAUZE CLEAN-WRAP BDGE N/S 4"

4 BLOODSTOPPER

1 NON-ADHERENT PADS 2"X3" 10'S

1 GZE PADS STERILE 2"X 2" 10'S

1 GZE PADS STERILE 3"X 3" 25'S

1 ELASTIC BANDAGE 3" X 4.5YD

1 CPR FILTERSHIELD 77-100

1 AYPANAL NON-ASP IND 2/ENV 100

1 4OZ BFS EYEWASH TRILINGUAL BOTTLE

1 SCISSOR BDGE 4" RED PLS HDL

1 KIT TWEEZER 3 1/2" SLANTED

LBL STOCK 6-3/8"X4"

1 LBL STOCK 3"x1-7/8"

2 2 PR LRG NITRILE GLVES ZIP BAG

2 BURN-STOP BURN DRESSING 4 X 4

2 TRI BNDG NON WOVEN 40"X40"X56"

2 COLD PACK UNIT 4"X6" BULK

Eyesaline
Principal Display Panel

Eyesaline

Alcohol Wipe
Principal Display Panel

OH Pak Alcohol Wipe

Aypanal
Principal Display Panel

Aypanal

Neomycin
Principal Display Panel

Neomycin

Antiseptic Spray
Principal Display Panel

Antiseptic Spray

Burn Spray
Principal Display Panel

Burn Spray

Hand sanitizer
Principal Display Panel

Hand Sanitizer

4264 Kit Label
FAK100CAB-CLSB

4264 label

4264 Kit Contnets
FAK100CAB-CLSB

1 1X3 PLASTIC 100/BOX

1 FINGERTIP "T" WOVEN 40/BOX

1 SWIFT KNUCKLE 40/BX

3 NEOMYCIN ANTIBIOTIC 10 PER

2 EYE DRESS PKT W/4 ADH STRIPS

1 TOURNIQUET, 1 PER

1 WIRE SPLINT 1 PER

1 ADH BAND, EXTRA LARGE, 6 PER

1 ALCOHOL PREP PADS 10P

1 O/H PUMP ANTISEPTIC 2 OZ ID F

1 O/H PUMP BURN RELIEF 2 OZ ID G

1 FIRST AID GUIDE ASHI

2 TAPE ADHESIVE 1"X 5 YD PLSTC

10 HAND SANITIZER 0.9G WJ BULK

4 GAUZE CLEAN-WRAP BDGE N/S 2"

4 GAUZE CLEAN-WRAP BDGE N/S 4"

4 BLOODSTOPPER

1 NON-ADHERENT PADS 2"X3" 10'S

1 GZE PADS STERILE 2"X 2" 10'S

1 GZE PADS STERILE 3"X 3" 25'S

1 ELASTIC BANDAGE 3" X 4.5YD

1 CPR FILTERSHIELD 77-100

1 4OZ BFS EYEWASH TRILINGUAL BOTTLE

1 SCISSOR BDGE 4" RED PLS HDL

1 KIT TWEEZER 3 1/2" SLANTED

1 LBL STOCK 6-3/8"X4"

1 LBL STOCK 4"X2-7/8"

8 PR LRG NITRILE GLVES ZIP BAG

2 WATER-JEL BURN DRESSING 4 X 4

1 KIT ST MED FA CABINET-SP SHELF

1 LBL CONTENTS ANSI 2015 CL B

1 LBL CAB CVR ANSI 2015 CL B

2 TRI BNDG NON WOVEN 40"X40"X56"

2 COLD PACK UNIT 4"X6" BULK

4265 Kit Label
FAK150CAB-CLSB

4265 label

4266 Kit Label
FAK200CAB-CLSB

4266 label

4310 Kit Label
SF00004442

4310 label

4400 Kit Label
FAKREF100-B

4400 LABEL

4400 FIRST AID KIT 
4400 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4400
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4400-011 in 1 KIT; Type 0: Not a Combination Product10/18/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 118 mL
Part 210 POUCH 4 mL
Part 350 PACKET 100 
Part 41 BOTTLE, SPRAY 59 mL
Part 51 BOTTLE, SPRAY 59 mL
Part 625 PACKET 22.5 g
Part 710 PACKAGE 9 mL
Part 1 of 7
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:0498-0100-02118 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 7
ALCOHOL WIPE 
isopropyl alcohol swab
Product Information
Item Code (Source)NDC:0498-0143
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0143-040.4 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/18/2018
Part 3 of 7
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
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code circle;U
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
12 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 4 of 7
BURN RELIEF 
lidocaine hydrochloride spray
Product Information
Item Code (Source)NDC:0498-0221
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS24.64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
TEA TREE OIL (UNII: VIF565UC2G)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0221-5959 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/18/2018
Part 5 of 7
ANTISEPTIC 
benzalkonium chloride spray
Product Information
Item Code (Source)NDC:0498-0402
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
OCTOXYNOL 9 (UNII: 7JPC6Y25QS)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TROLAMINE (UNII: 9O3K93S3TK)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0402-5959 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/18/2018
Part 6 of 7
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 7 of 7
INSTANT HAND SANITIZER 
alcohol liquid
Product Information
Item Code (Source)NDC:59898-420
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
WATER (UNII: 059QF0KO0R)  
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59898-420-360.9 mL in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/15/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/18/201806/03/2024
4264 FIRST AID KIT 
4264 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4264
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4264-011 in 1 KIT; Type 0: Not a Combination Product10/18/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 118 mL
Part 210 POUCH 4 mL
Part 350 PACKET 100 
Part 41 BOTTLE, SPRAY 59 mL
Part 51 BOTTLE, SPRAY 59 mL
Part 630 PACKET 27 g
Part 710 PACKAGE 9 mL
Part 1 of 7
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:0498-0100-02118 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 7
ALCOHOL WIPE 
isopropyl alcohol swab
Product Information
Item Code (Source)NDC:0498-0143
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0143-040.4 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/18/2018
Part 3 of 7
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
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code circle;U
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
12 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 4 of 7
BURN RELIEF 
lidocaine hydrochloride spray
Product Information
Item Code (Source)NDC:0498-0221
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS24.64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
TEA TREE OIL (UNII: VIF565UC2G)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0221-5959 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/18/2018
Part 5 of 7
ANTISEPTIC 
benzalkonium chloride spray
Product Information
Item Code (Source)NDC:0498-0402
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
OCTOXYNOL 9 (UNII: 7JPC6Y25QS)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TROLAMINE (UNII: 9O3K93S3TK)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0402-5959 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/18/2018
Part 6 of 7
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 7 of 7
INSTANT HAND SANITIZER 
alcohol liquid
Product Information
Item Code (Source)NDC:59898-420
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
WATER (UNII: 059QF0KO0R)  
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59898-420-360.9 mL in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/15/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/18/201806/03/2024
4266 FIRST AID KIT 
4266 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4266
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4266-011 in 1 KIT; Type 0: Not a Combination Product10/18/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 BOTTLE 236 mL
Part 220 POUCH 8 mL
Part 3100 PACKET 200 
Part 42 BOTTLE, SPRAY 108 mL
Part 52 BOTTLE, SPRAY 108 mL
Part 630 PACKET 27 g
Part 730 PACKAGE 27 mL
Part 1 of 7
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:0498-0100-02118 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 7
ALCOHOL WIPE 
isopropyl alcohol swab
Product Information
Item Code (Source)NDC:0498-0143
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0143-040.4 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/18/2018
Part 3 of 7
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
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code circle;U
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
12 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 4 of 7
BURN RELIEF 
lidocaine hydrochloride spray
Product Information
Item Code (Source)NDC:0498-0221
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS24.64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
TEA TREE OIL (UNII: VIF565UC2G)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0221-5959 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/18/2018
Part 5 of 7
ANTISEPTIC 
benzalkonium chloride spray
Product Information
Item Code (Source)NDC:0498-0402
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
OCTOXYNOL 9 (UNII: 7JPC6Y25QS)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TROLAMINE (UNII: 9O3K93S3TK)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0402-5959 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/18/2018
Part 6 of 7
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 7 of 7
INSTANT HAND SANITIZER 
alcohol liquid
Product Information
Item Code (Source)NDC:59898-420
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
WATER (UNII: 059QF0KO0R)  
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59898-420-360.9 mL in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/15/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/18/201806/03/2024
4265 FIRST AID KIT 
4265 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4265
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4265-011 in 1 KIT; Type 0: Not a Combination Product10/18/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 118 mL
Part 210 POUCH 4 mL
Part 350 PACKET 100 
Part 42 BOTTLE, SPRAY 108 mL
Part 52 BOTTLE, SPRAY 108 mL
Part 630 PACKET 27 g
Part 720 PACKAGE 18 mL
Part 1 of 7
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:0498-0100-02118 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 7
ALCOHOL WIPE 
isopropyl alcohol swab
Product Information
Item Code (Source)NDC:0498-0143
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0143-040.4 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/18/2018
Part 3 of 7
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
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code circle;U
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
12 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 4 of 7
BURN RELIEF 
lidocaine hydrochloride spray
Product Information
Item Code (Source)NDC:0498-0221
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS24.64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
TEA TREE OIL (UNII: VIF565UC2G)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0221-5959 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/18/2018
Part 5 of 7
ANTISEPTIC 
benzalkonium chloride spray
Product Information
Item Code (Source)NDC:0498-0402
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
OCTOXYNOL 9 (UNII: 7JPC6Y25QS)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TROLAMINE (UNII: 9O3K93S3TK)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0402-5959 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/18/2018
Part 6 of 7
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 7 of 7
INSTANT HAND SANITIZER 
alcohol liquid
Product Information
Item Code (Source)NDC:59898-420
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
WATER (UNII: 059QF0KO0R)  
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59898-420-360.9 mL in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/15/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/18/201806/03/2024
4310 FIRST AID KIT 
4310 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4310
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4310-011 in 1 KIT; Type 0: Not a Combination Product10/18/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, SPRAY 59 mL
Part 230 PACKET 27 g
Part 310 PACKAGE 9 mL
Part 41 BOTTLE 118 mL
Part 510 POUCH 4 mL
Part 650 PACKET 100 
Part 71 BOTTLE, SPRAY 59 mL
Part 1 of 7
ANTISEPTIC 
benzalkonium chloride spray
Product Information
Item Code (Source)NDC:0498-0402
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
OCTOXYNOL 9 (UNII: 7JPC6Y25QS)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TROLAMINE (UNII: 9O3K93S3TK)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0402-5959 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/18/2018
Part 2 of 7
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 3 of 7
INSTANT HAND SANITIZER 
alcohol liquid
Product Information
Item Code (Source)NDC:59898-420
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
WATER (UNII: 059QF0KO0R)  
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59898-420-360.9 mL in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/15/2010
Part 4 of 7
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:0498-0100-02118 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 5 of 7
ALCOHOL WIPE 
isopropyl alcohol swab
Product Information
Item Code (Source)NDC:0498-0143
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0143-040.4 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/18/2018
Part 6 of 7
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
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code circle;U
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
12 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 7 of 7
BURN RELIEF 
lidocaine hydrochloride spray
Product Information
Item Code (Source)NDC:0498-0221
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS24.64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
TEA TREE OIL (UNII: VIF565UC2G)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0221-5959 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/18/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/18/201806/03/2024
Labeler - Honeywell Safety Products USA, INC (118768815)

Revised: 6/2024
 
Honeywell Safety Products USA, INC