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Name:Burn-b Gone Otc
Manufacturer:Dewitt Laboratories, Inc
Category:Over-the-counter (OTC) Marketed Drugs


Burn-B Gone OTC 75g Tube

BURN-B GONE OTC  - allantoin gel 
DeWitt Laboratories, Inc

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-B Gone OTC 75g Tube


Active Ingredient:  Allantoin 1.0%


Purpose:  Skin Protectant


Uses:
Temporarily protects skin after minor

  • burns
  • scrapes
  • cuts
  • Helps prevent, temporarily protects, and helps relieve chapped or cracked skin.
  • Helps prevent and protect skin from the drying effects of wind and cold weather.


Warnings: 

For External Use Only



When using this product avoid contact with eyes.


Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again 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 - Cleanse affected area thoroughly.  Apply 3-4 times daily.
  • Children under 2 years old - Consult a doctor.


Other Information:  Store between 15-30C (59-86F)


Inactive Ingredients:  Water (Aqua), SD Alcohol 40, Glycerin, Astragalus Gummifer Gum, Carbomer, Boric Acid, Disodium EDTA, Ethyl Ether, Triethanolamine, Methylparaben, Propylparaben


Questions or comments?

www.BurnBGoneOTC.com


Burn-B_Gone_OTC 75g Tube Artwork





BURN-B GONE OTC 
allantoin gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51483-002
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Allantoin (Allantoin) Allantoin 0.75 g  in 75 g
Inactive Ingredients
Ingredient Name Strength
Water  
Alcohol  
Glycerin  
Tragacanth  
Carbomer Homopolymer Type C  
Boric Acid  
Edetate Disodium  
Ether  
Trolamine  
Methylparaben  
Propylparaben  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51483-002-20 75 g in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 06/01/2010

Labeler - DeWitt Laboratories, Inc (040211711)
Registrant - Quantum Labs LLC (932206126)
Establishment
Name Address ID/FEI Operations
Quantum Labs LLC 932206126 manufacture

Revised: 06/2010 DeWitt Laboratories, Inc



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


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