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North Burn Jel

Medically reviewed on December 17, 2017

Dosage form: gel
Ingredients: LIDOCAINE HYDROCHLORIDE 2g in 100mL
Labeler: North Safety Products
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.

North Burn Jel

Active ingredient

Lidocaine HCl 2.0 %

Purpose

External analgesic

Uses

for the temporary relief of pain associated with minor burns

Directions
  • adults and children 2 years of age and older; apply to affected area not more than 3 to 4 times daily
  • spread a thick even layer over affected skin
  • children under 2 years of age: consult a doctor

Warnings

For external use only

Do not use
  • on large areas of the body
  • on broken, blistered or oozing skin

When using this product
  • avoid contact with eyes

Stop use and ask a doctor if
  • conditions worsens
  • symptoms persist for more than 7 days
  • condition clears up and occurs again within a few days

Keep out of reach of children

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

Other information
  • store at room temperature
  • do not use if opened or torn
  • you may report a serious adverse reaction to this product to 800-430-5490

Inactive ingredients

acrylates C/10-30 alkyl acrylate, carbomer, diazolidinyl urea, disodium EDTA, glycerin, melaleuca alternifolia (tea tree) leaf oil, methylparaben, propylene glycol, propylparaben, trolamine

Questions

1-800-430-5490

Principal Display Panel

North Burn Jel.jpg

North 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 finalpart34812/08/2017
Labeler - North Safety Products (019777263)
Registrant - North Safety Products (019777263)
Establishment
NameAddressID/FEIOperations
North Safety Products019777263pack(0498-0200)
Establishment
NameAddressID/FEIOperations
Water-Jel Technologies155522589manufacture(0498-0200)

 
North Safety Products

Further information

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

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