4188 FIRST AID KIT- 4188 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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4188 First Aid Kit (Burn Jel, Ammonia Inh) 10704-4299

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

4188
010704-4299 Kit Contents

2 AMMONIA INHALANTS 10 PER

2 TOURNIQUET, 1 PER

15 TRIANGULAR BDG, NON-STERILE

4 BANDAGE COMP, 2" OFFSET, 4 PER

8 BANDAGE COMP, 4" OFFSET, 1 PER

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

1 BURN JEL 1/8 OZ, 6 PER

LBL STOCK 6-3/8"X4"

1 LBL STOCK 3"x1-7/8"

1 KIT STL 36 UN WHT 01 HOR SHELF

1 LABL INSTR 24 & 36 UNIT KITS

Principal Display Panel

Inhalant

Burn Jel
Principal Display Panel

Burn Jel

4188 Kit Label
010704-4299

4299  750982 Kit Label

4188 FIRST AID KIT 
4188 first aid kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-4188
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-4188-011 in 1 KIT09/13/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 16 PACKET 21 g
Part 220 AMPULE 6 mL
Part 1 of 2
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 2 of 2
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
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(0498-4188)
Establishment
NameAddressID/FEIBusiness Operations
Water-Jel Technologies155522589manufacture(0498-0203)

Revised: 3/2019
Document Id: 839f7c69-f011-09c3-e053-2a91aa0ab612
Set id: 839f7c69-f010-09c3-e053-2a91aa0ab612
Version: 1
Effective Time: 20190308
 
Honeywell Safety Products USA, Inc.