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North Burn Jel

Dosage form: gel
Ingredients: LIDOCAINE HYDROCHLORIDE 2g in 100mL
Labeler: Honeywell Safety Products USA, Inc
NDC Code: 0498-0200

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Burn Jel

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

Principal Display Panel

Honeywell Burn Jel

Burn Jel

NORTH BURN JEL 
gel for burns gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-0200
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) 
GLYCERIN 
TEA TREE OIL 
DIAZOLIDINYL UREA 
TROLAMINE 
PROPYLPARABEN 
METHYLPARABEN 
OCTOXYNOL-9 
DIPROPYLENE GLYCOL 
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) 
EDETATE DISODIUM (EDETIC ACID)  
Packaging
#Item CodePackage Description
1NDC:0498-0200-3410 PACKET in 1 CARTON
13.5 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/08/201709/18/2018
BURN JEL 
gel for burns gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-0202
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) 
GLYCERIN 
TEA TREE OIL 
DIAZOLIDINYL UREA 
TROLAMINE 
PROPYLPARABEN 
METHYLPARABEN 
OCTOXYNOL-9 
DIPROPYLENE GLYCOL 
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) 
EDETATE DISODIUM (EDETIC ACID)  
Packaging
#Item CodePackage Description
1NDC:0498-0202-3410 PACKET in 1 CARTON
1NDC:0498-0202-003.5 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/18/201809/19/2018
BURN JEL 
gel for burns gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-0203
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) 
GLYCERIN 
TEA TREE OIL 
DIAZOLIDINYL UREA 
TROLAMINE 
PROPYLPARABEN 
METHYLPARABEN 
OCTOXYNOL-9 
DIPROPYLENE GLYCOL 
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) 
EDETATE DISODIUM (EDETIC ACID)  
Packaging
#Item CodePackage Description
1NDC:0498-0203-3410 PACKET in 1 CARTON
1NDC:0498-0203-003.5 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/19/2018
Labeler - Honeywell Safety Products USA, Inc (079287321)
Registrant - Honeywell Safety Products USA, Inc (079287321)
Establishment
NameAddressID/FEIOperations
Honeywell Safety Products USA, Inc079287321pack(0498-0200, 0498-0202, 0498-0203)

 
Honeywell Safety Products USA, Inc

Medically reviewed on Sep 19, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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