4043 First Aid Kit (Burn Jel- SF00003612)

Drug Labeling and Warnings

Drug Details [pdf]

4043 FIRST AID KIT- 4043 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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4043 First Aid Kit (Burn Jel- SF00003612)

Active ingredient

Lidocaine HCl 2.0 %

Purpose

External analgesic

Uses

temporarily relieves pain due to minor burns

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.

Directions

  • adults and children 2 years of age and older; apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor
  • you may report a serious reaction to this product to 800-430-5490

Other information

  • store at room temperature
  • do not use if opened or torn

Inactive ingredients

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

Questions

1-800-430-5490

4043
SF00003612 Kit Contents

BURN JEL 1/8 OZ, 6 PER

CO-FLEX LATEX FREE 2"X5YD TAN

WATER JEL FACIAL DRS 12X16 EA

LBL STOCK 6-3/8"X4"

LBL STOCK 3"x1-7/8"

WATER-JEL BURN DRESSING 8 X 18

Principal Display Panel

Burn Jel

Honeywell Burn Jel

Burn jel

4043 Kit Label
SF00003612

4043 kit label

4043 FIRST AID KIT 
4043 first aid kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0498-4043
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0498-4043-011 in 1 KIT; Type 0: Not a Combination Product11/21/201810/18/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 16 PACKET 21 g
Part 1 of 1
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)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0498-0203-341 in 1 CARTON
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 other11/21/201810/18/2019
Labeler - Honeywell Safety Products USA, Inc (079287321)
Registrant - Honeywell Safety Products USA, Inc (079287321)
Establishment
NameAddressID/FEIBusiness Operations
Honeywell Safety Products USA, Inc079287321pack(0498-0203, 0498-4043)

Revised: 10/2019
Document Id: 953798e4-745e-5e1a-e053-2995a90a18f1
Set id: 7b353781-5fcc-4691-e053-2991aa0ac925
Version: 2
Effective Time: 20191018