4379 FIRST AID KIT- 4379 first aid kit 
4334 FIRST AID KIT- 4334 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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0498-4334 & 0498-4379: First Aid Kit (triple, Burn Jel, alcohol wipe, PVP wipe, BZK, sting relief, Foille, aypanal EX- Z019819, Z63158006)

Triple
Active ingredients

Bacitracin zinc 400 units

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

Polymyxin B sulfate 5000 units

Triple
Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Triple
Uses

Triple
Warnings

For external use only

Allergy alert do not use if you are allergic to any of the ingredients

Do not use

  • in the eyes
  • over large areas of the body

Ask a doctor before use if you have

  • a 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 the reach of children

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

Triple
Directions

Triple
Other information

Triple
Inactive ingredient

petrolatum

Alcohol
Active ingredient

Isopropyl alcohol 70%

Alcohol
Purpose

First aid antiseptic

Alcohol
Uses

Alcohol
Warnings

For external use only

Flammable, keep away from fire or flame.

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

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
Directions

Alcohol
Other information

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

Alcohol
Inactive ingredient

water

Foille
Active ingredient


Benzocaine 5.0% (w/w)

Chloroxylenol 0.1% (w/w)

Foille
Purpose

External analgesic

Antiseptic

Foille
Uses

Foille
Warnings

For external use only

When using this product

  • avoid contact with the eyes

Stop use and ask a doctor if

  • condition worsens, or symptoms persist for more than 7 days or clear up and occur again within a few days.
  • Do not apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

Keep out of reach of children.

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

Foille
Directions

Foille
Other information

Avoid contact with clothing

Foille may stain certain fabrics

Foille
Inactive ingredients

beeswax, benzyl alcohol, calcium disodium EDTA, calcium hydroxide, ceresin, eugenol, hydrogenated vegetable oil, maleic anhydride, mono- and di-glycerides, PEG-32, purified water, sodium borate, sodium lauryl sulfate, zea mays (corn) oil.

Burn Jel
Active ingredient

Lidocaine HCl 2.0 %v

Burn Jel
Purpose

External analgesic

Burn Jel
Uses

Burn Jel
Warnings

For external use oonly

Do not use

  • on large areas of the body, particularly over raw surfaces or blistered areas

When using this product

  • avoid contact with eyes

Stop use and ask a doctor if

  • the condition gets worse
  • symptoms persist for more than 7 days
  • condition clears up and recurs within a few days

Keep out of reach of children


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

Burn Jel
Directions

Burn Jel
Other information

Burn Jel
Inactive ingredients

carbopol 940, carbopol 1342, diazolidinyl urea, glycerin, melaleuca alternifolia (tea tree) leaf oil, methylparaben, octoxynol-9, propylene glycol, propylparaben, trolamine, water

Burn Jel
Questions

1-800-430-5490

Sting Relief
Active ingredients (in each wipe)

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

PVP Wipe
Active ingredient


Povidone-iodine 10% (equivalent to 1% titratable iodine)

PVP
Purpose

First aid antiseptic

PVP
USes

PVP
Warnings

For external use only.

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 or persists for more than 72 hours
  • irritation and redness develops

Keep out of reach of children.

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

PVP
Directions

PVP
Other information

PVP
Inactive ingredients

nonoxynol 9, water

PVP
Questions

800-430-5490

Aypanal EX
Active ingredient

Acetaminophen 500 mg

Aypanal EX
Purpose

Pain reliever/fever reducer

Aypanal EX
Uses

Aypanal EX
Warnings

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take:

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

If skin reaction 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 use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

Keep out of reach of children.

Overdose warning: In case ofl overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

If pregnant or breastfeeding,

  • ask a health professional before use.

Aypanal EX
Directions

Aypanal EX
Other information

store at room temperature 15 0 -30 0 C (59 0 -86 0 F)
TAMPER EVIDENT- DO NOT USE IF OPEN OR TORN

Aypanal EX
Inactive ingredients

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

Aypanal EX
Questions or Comments?

1-800-430-5490

BZK
Active ingredient

Benzalkonium chloride 0.13% w/v

BZK
Purpose

First aid antiseptic

BZK
Uses

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

BZK
Warnings

For external use only

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

4334
Z019819 KIT CONTENTS

1 TRIPLE ANTIBIOTIC 10 PER

1 INSTANT COLD PACK 4" X 6"

2 ADHESIVE BDG,PLSTIC,1"X3"16PER

1 BURN JEL 1/8 OZ, 6 PER

1 ALCOHOL PREP PADS 10P

1 PVP IODINE WIPES 10 PER

1 NITRILE GLOVES 2PR BBP

1 ANTIMCRBL ANTSPTC TWLETTS

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

1 TWEEZER PLASTICS 4"

1 FLEXICON 2"X 4.1 YD

1 FIRST AID GUIDE ASHI

1 ABD COMBINE PAD 5" X 9"

1 SCISSOR BDGE 4" RED PLS HDL

LBL STOCK 6-3/8"X4"

LBL STOCK 4"X2-7/8"

1 LBL STOCK 3"x1-7/8"

1 LBL CONTS 6 3/4"X3 1/2" ID B

1 LABEL COVER, GRAINGER Z019819

1 KIT PP 24 UNIT FA

3 SAFETEC STING RELIEF WIPES BULK

1 FOILLE BURN/F A OINT 1/2 OZ

4 GAUZE PADS 2"X2" 12PLY

1 GAUZE PADS 4"X4" 12PLY

4 WOVEN FINGERTIP BANDAGE 2"

4 WOVEN KNUCKLE BANDAGE

4 HEAVY FLEX LARGE PATCH 2" X 3"

1 GAUZE PADS 3"X3" 4/BX

1 TRIANG 37X37X52 UNIT

8 AYPANAL EXTRA BULK 2/PK

4379
Z63158002 Kit Contents

1 TRIPLE ANTIBIOTIC 10 PER

1 INSTANT COLD PACK 4" X 6"

2 ADHESIVE BDG,PLSTIC,1"X3"16PER

1 BURN JEL 1/8 OZ, 6 PER

1 ALCOHOL PREP PADS 10P

1 PVP IODINE WIPES 10 PER

1 NITRILE GLOVES 2PR BBP

1 ANTIMCRBL ANTSPTC TWLETTS

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

1 TWEEZER PLASTICS 4"

1 FLEXICON 2"X 4.1 YD

1 FIRST AID GUIDE ASHI

1 ABD COMBINE PAD 5" X 9"

1 SCISSOR BDGE 4" RED PLS HDL

LBL STOCK 6-3/8"X4"

LBL STOCK 4"X2-7/8"

1 LBL STOCK 3"x1-7/8"

1 LBL CONTS 6 3/4"X3 1/2" ID B

1 LABEL COVER, GRAINGER Z019819

1 KIT PP 24 UNIT FA

3 SAFETEC STING RELIEF WIPES BULK

1 FOILLE BURN/F A OINT 1/2 OZ

4 GAUZE PADS 2"X2" 12PLY

1 GAUZE PADS 4"X4" 12PLY

4 WOVEN FINGERTIP BANDAGE 2"

4 WOVEN KNUCKLE BANDAGE

4 HEAVY FLEX LARGE PATCH 2" X 3"

1 GAUZE PADS 3"X3" 4/BX

1 TRIANG 37X37X52 UNIT

8 AYPANAL EXTRA BULK 2/PK

Triple
Principal Display Panel

Triple Antibiotic

Alcohol
Principal Display Panel

Alcohol Preps

Foille
Principal Display Panel

Foille

Burn Jel
Principal Display Panel

Burn Jel

Sting Relief
Principal Display Panel

Sting Relief

PVP
Principal Display Panel

PVP Wipe

Aypanal EX
Principal Display Panel

aypanal ex

BZK
Principal Display Panel

Antiseptic Towelette

4334 Kit Label
Z019819

4334 label

4373 Kit Label
Z63158002

4379 label

4379 FIRST AID KIT 
4379 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4379
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4379-011 in 1 KIT; Type 0: Not a Combination Product10/18/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 16 PACKET 21 g
Part 210 POUCH 4 mL
Part 31 TUBE 14 g
Part 41 PACKET 1.4 mL
Part 53 POUCH 1.2 mL
Part 610 POUCH 3 mL
Part 78 PACKET 16 
Part 810 PACKET 9 g
Part 1 of 8
BURN JEL 
gel for burns gel
Product Information
Item Code (Source)NDC:0498-0203
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
TEA TREE OIL (UNII: VIF565UC2G)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0203-003.5 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/19/2018
Part 2 of 8
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
OTC monograph not finalpart333A09/18/2018
Part 3 of 8
BLISTEX   FOILLE MEDICATED FIRST AID
benzocaine and chloroxylenol ointment
Product Information
Item Code (Source)NDC:10157-9302
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.1 g  in 100 g
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
CERESIN (UNII: Q1LS2UJO3A)  
EUGENOL (UNII: 3T8H1794QW)  
MALEIC ANHYDRIDE (UNII: V5877ZJZ25)  
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
CORN OIL (UNII: 8470G57WFM)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CALCIUM HYDROXIDE (UNII: PF5DZW74VN)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
114 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/05/2013
Part 4 of 8
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
1NDC:0498-0501-001.4 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E12/21/2017
Part 5 of 8
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
MENTHOL (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
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
OTC monograph not finalpart34812/23/2017
Part 6 of 8
PVP IODINE WIPE 
povidone-iodine 10% swab
Product Information
Item Code (Source)NDC:0498-0121
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
NONOXYNOL-9 (UNII: 48Q180SH9T)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0121-000.3 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 7 of 8
AYPANAL EX 
acetaminophen tablet
Product Information
Item Code (Source)NDC:0498-2110
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize12mm
FlavorImprint Code FR1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-2110-012 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/02/2017
Part 8 of 8
TRIPLE ANTIBIOTIC 
bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment
Product Information
Item Code (Source)NDC:0498-0750
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0750-350.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B09/19/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/18/2018
4334 FIRST AID KIT 
4334 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4334
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4334-011 in 1 KIT; Type 0: Not a Combination Product10/18/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 PACKET 1.4 mL
Part 23 POUCH 1.2 mL
Part 310 POUCH 3 mL
Part 48 PACKET 16 
Part 510 PACKET 9 g
Part 610 POUCH 4 mL
Part 71 TUBE 14 g
Part 86 PACKET 21 g
Part 1 of 8
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
1NDC:0498-0501-001.4 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E12/21/2017
Part 2 of 8
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
MENTHOL (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
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
OTC monograph not finalpart34812/23/2017
Part 3 of 8
PVP IODINE WIPE 
povidone-iodine 10% swab
Product Information
Item Code (Source)NDC:0498-0121
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
NONOXYNOL-9 (UNII: 48Q180SH9T)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0121-000.3 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 4 of 8
AYPANAL EX 
acetaminophen tablet
Product Information
Item Code (Source)NDC:0498-2110
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize12mm
FlavorImprint Code FR1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-2110-012 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/02/2017
Part 5 of 8
TRIPLE ANTIBIOTIC 
bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment
Product Information
Item Code (Source)NDC:0498-0750
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0750-350.9 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B09/19/2018
Part 6 of 8
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
OTC monograph not finalpart333A09/18/2018
Part 7 of 8
BLISTEX   FOILLE MEDICATED FIRST AID
benzocaine and chloroxylenol ointment
Product Information
Item Code (Source)NDC:10157-9302
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.1 g  in 100 g
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
CERESIN (UNII: Q1LS2UJO3A)  
EUGENOL (UNII: 3T8H1794QW)  
MALEIC ANHYDRIDE (UNII: V5877ZJZ25)  
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
CORN OIL (UNII: 8470G57WFM)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CALCIUM HYDROXIDE (UNII: PF5DZW74VN)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
114 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/05/2013
Part 8 of 8
BURN JEL 
gel for burns gel
Product Information
Item Code (Source)NDC:0498-0203
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
TEA TREE OIL (UNII: VIF565UC2G)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0203-003.5 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/19/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/18/2018
Labeler - Honeywell Safety Products USA, INC (079287321)

Revised: 12/2021
Document Id: d30e877a-1bc9-b186-e053-2995a90a38ee
Set id: 8ae4b762-6666-b601-e053-2995a90ad1b9
Version: 4
Effective Time: 20211213
 
Honeywell Safety Products USA, INC