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Name:Burn Jel
Manufacturer:Water-jel Technologies
Category:Over-the-counter (OTC) Marketed Drugs


Burn Jel

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.

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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 Type HUMAN OTC DRUG Item Code (Source) NDC:59898-200
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE 2.0 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
CARBOMER HOMOPOLYMER TYPE C  
GLYCERIN  
PROPYLENE GLYCOL  
METHYLPARABEN  
TEA TREE OIL  
DIAZOLIDINYLUREA  
TROLAMINE  
OCTOXYNOL 9  
CARBOMER COPOLYMER TYPE B  
PROPYLPARABEN  
EDETATE DISODIUM  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59898-200-13 24 BOTTLE, PLASTIC ( BOTTLE) in 1 CARTON contains a BOTTLE, PLASTIC (59898-200-12)
1 NDC:59898-200-12 118 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (59898-200-13)
2 NDC:59898-200-15 25 PACKET ( PACKET) in 1 BOX, UNIT-DOSE contains a PACKET
2 3.5 mL in 1 PACKET This package is contained within the BOX, UNIT-DOSE (59898-200-15)
3 NDC:59898-200-16 6 PACKET ( PACKET) in 1 BOX, UNIT-DOSE contains a PACKET
3 3.5 mL in 1 PACKET This package is contained within the BOX, UNIT-DOSE (59898-200-16)
4 NDC:59898-200-11 24 BOTTLE, PLASTIC ( BOTTLE) in 1 CARTON contains a BOTTLE, PLASTIC (59898-200-10)
4 NDC:59898-200-10 59 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (59898-200-11)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 04/17/2010

Labeler - Water-Jel Technologies (155522589)
Registrant - Water-Jel Technologies (155522589)
Establishment
Name Address ID/FEI Operations
Water-Jel Technologies 155522589 manufacture

Revised: 04/2010 Water-Jel Technologies



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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