BURN-B GONE OTC (ALLANTOIN) GEL [DEWITT LABORATORIES, INC]

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BURN-B GONE OTC (ALLANTOIN) GEL [DEWITT LABORATORIES, INC]
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NDC 51483-002-20
Set ID 0061a03b-4886-44ae-a0e1-f0336ee5d2e6
Category HUMAN OTC DRUG LABEL
Packager DeWitt Laboratories, Inc
Generic Name
Product Class
Product Number
Application Number PART347
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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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