BURN JEL - lidocaine hydrochloride gel 
Water-Jel Technologies

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

for the temporary relief of pain associated with minor burns

Warnings

For external use only

Do not use

  • in large quantities, particularly over raw surfaces or blistered areas

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 the 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: consult a doctor

Other information

  • spread a thick even layer of Burn Jel over affected area.

Inactive ingredients

carbomer 940, carbomer 1342, diazolidinyl urea, edetate disodium, glycerin, methylparaben, octoxynol 9, propylene glycol, propylparaben, purified water, tea tree oil, trolamine

Questions

1-800-275-3433 Weekdays 9 AM - 5 PM EST

Principal Display Panel

Image of PDP
BURN JEL 
gel for burns gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59898-200
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE2.0 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C 
GLYCERIN 
PROPYLENE GLYCOL 
METHYLPARABEN 
TEA TREE OIL 
DIAZOLIDINYLUREA 
TROLAMINE 
OCTOXYNOL 9 
CARBOMER COPOLYMER TYPE B 
PROPYLPARABEN 
EDETATE DISODIUM 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59898-200-1324 in 1 CARTON
1NDC:59898-200-12118 mL in 1 BOTTLE, PLASTIC
2NDC:59898-200-1525 in 1 BOX, UNIT-DOSE
23.5 mL in 1 PACKET
3NDC:59898-200-166 in 1 BOX, UNIT-DOSE
33.5 mL in 1 PACKET
4NDC:59898-200-1124 in 1 CARTON
4NDC:59898-200-1059 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/17/2010
Labeler - Water-Jel Technologies (155522589)
Registrant - Water-Jel Technologies (155522589)
Establishment
NameAddressID/FEIBusiness Operations
Water-Jel Technologies155522589manufacture

Revised: 4/2010
Document Id: 5313a6bd-8854-41aa-9c21-e6daaabc4cb9
Set id: ff621b46-2342-41db-994d-851a09796d08
Version: 1
Effective Time: 20100417
 
Water-Jel Technologies