4192 FIRST AID KIT- 4192 first aid 
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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4192 First Aid Kit (Ammonia Inh, Burn Jel, PVP wipes) 011077-4258

Active ingredient

Ammonia 15%

Purpose

Respiratory stimulant

Uses

to prevent or treat fainting

Warnings

For external use only

Do not use

  • if you have asthma or emphysema

Stop use and ask a doctor if

  • condition persists

Keep out of reach of children

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

Directions

Other information

store at room temperature away from light

Inactive ingredients

alcohol USP, FD&C red #40, lavender oil, lemon oil fcc, nutmeg oil, purified water

Questions or Comments

1-800-430-5490

Burn Jel
Active ingredient

Lidocaine HCl 2.0%

Burn Jel
Purpose

External analgesic

Burn Jel
Uses

Burn Jel
Warnings

For external use only

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

4192
011077-4258 Kit Contents

1 KNUCKLE BAND 8 PER

2 AMMONIA INHALANTS 10 PER

1 EYE DRESS PKT W/4 ADH STRIPS

2 GAUZE BANDAGE, 4" X 6 YD

2 TRIANGULAR BDG, NON-STERILE

2 GAUZE PADS, 3" X 3", 4 PER

1 ADH TAPE, .5" X 2.5 YD, 2 PER

1 INSTANT COLD PACK 4" X 6"

2 BANDAGE COMP, 2" OFFSET, 4 PER

2 BANDAGE COMP, 4" OFFSET, 1 PER

2 BURN JEL 1/8 OZ, 6 PER

3 PVP IODINE WIPES 10 PER

3 ADH BDG, CLOTH, 1"X3", 16 PER

LBL STOCK 6-3/8"X4"

LBL STOCK 4"X2-7/8"

1 LBL STOCK 3"x1-7/8"

1 KIT STL 24 UN WHITE 01

1 LABL INSTR 24 & 36 UNIT KITS

Principal Display Panel

Inhalant

Burn Jel
Principal Display Panel

Burn Jel

4192 Kit Label
011077-4258

4192 label

4192 FIRST AID KIT 
4192 first aid kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4192
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4192-011 in 1 KIT09/13/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 120 AMPULE 6 mL
Part 212 PACKET 42 g
Part 330 POUCH 9 mL
Part 1 of 3
AMMONIA INHALENT 
ammonia inhalent inhalant
Product Information
Item Code (Source)NDC:0498-3334
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X) AMMONIA0.045 g  in 0.3 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-3334-000.3 mL in 1 AMPULE; 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 3
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
TEA TREE OIL (UNII: VIF565UC2G)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
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)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
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 3 of 3
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
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/13/2018
Labeler - Honeywell Safety Products USA, Inc. (079287321)
Registrant - Honeywell Safety Products USA, Inc. (079287321)
Establishment
NameAddressID/FEIBusiness Operations
James Alexander040756421manufacture(0498-3334)
Establishment
NameAddressID/FEIBusiness Operations
Honeywell Safety Products USA, Inc079287321pack(0498-4192)
Establishment
NameAddressID/FEIBusiness Operations
Water-Jel Technologies155522589manufacture(0498-0203)
Establishment
NameAddressID/FEIBusiness Operations
Sion Biotext Medical532775194manufacture(0498-0121)

Revised: 3/2019
Document Id: 83ad7cee-2688-8896-e053-2991aa0aee73
Set id: 83ad7c3e-775d-c060-e053-2991aa0a500c
Version: 1
Effective Time: 20190309
 
Honeywell Safety Products USA, Inc.