Label: BURN-B GONE OTC- allantoin gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated June 1, 2010

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  • ACTIVE INGREDIENT


    Active Ingredient:  Allantoin 1.0%
  • PURPOSE


    Purpose:  Skin Protectant
  • INDICATIONS & USAGE


    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


    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.

  • WHEN USING


    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.

  • STORAGE AND HANDLING


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


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


    Questions or comments?

    www.BurnBGoneOTC.com

  • PRINCIPAL DISPLAY PANEL


    Burn-B_Gone_OTC 75g Tube Artwork
  • INGREDIENTS AND APPEARANCE
    BURN-B GONE OTC 
    allantoin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51483-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Allantoin (UNII: 344S277G0Z) (Allantoin - UNII:344S277G0Z) Allantoin0.75 g  in 75 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Alcohol (UNII: 3K9958V90M)  
    Glycerin (UNII: PDC6A3C0OX)  
    Tragacanth (UNII: 2944357O2O)  
    Carbomer Homopolymer Type C (UNII: 4Q93RCW27E)  
    Boric Acid (UNII: R57ZHV85D4)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Ether (UNII: 0F5N573A2Y)  
    Trolamine (UNII: 9O3K93S3TK)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51483-002-2075 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/01/2010
    Labeler - DeWitt Laboratories, Inc (040211711)
    Registrant - Quantum Labs LLC (932206126)
    Establishment
    NameAddressID/FEIBusiness Operations
    Quantum Labs LLC932206126manufacture
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