Label: COOL MELON- allantoin cream

  • Category: HUMAN OTC DRUG LABEL

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 October 6, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient

    Allantoin, 0.5%

  • PURPOSE

    Purpose

    Skin protectant

  • INDICATIONS & USAGE

    Uses

    Helps relieve chapped or cracked skin

    Helps prevent and protect from the drying effects of wind and cold weather

  • WARNINGS

    Warnings

    For external use only

    When using this product avoid contact with the eyes.

    In case of eye contact, flush with water.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Apply to clean hands

    Rub in well

    Re-apply after handwashing or as needed

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, Cetyl Esters, Petrolatum, Isoproply Palmitate, Stearyl Alcohol, Ceteareth-20, Chloroxylenol, Carbomer, PEG-75 Lanolin, Hydroxyethylcellulose, Methylparaben, Ethanolamine, Propylparaben, Fragrance.

  • PRINCIPAL DISPLAY PANEL

    Cool Melon

    Medicated Skin Cream

    Non-Greasy, Silicone-Free

    Conditions and relieves dry, hard-working hands

    deb

    Proudly made in the USA by Deb

    40227-00-100

    1 Liter - 33.8 Fluid Ounces 

    container label

  • INGREDIENTS AND APPEARANCE
    COOL MELON 
    allantoin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11084-042
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    CARBOMER 934 (UNII: Z135WT9208)  
    HYDROXYETHYL CELLULOSE (4000 CPS AT 1%) (UNII: ZYD53NBL45)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHANOLAMINE (UNII: 5KV86114PT)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11084-042-271000 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/01/2010
    Labeler - Deb USA, Inc. (607378015)
    Establishment
    NameAddressID/FEIBusiness Operations
    Deb USA, Inc.607378015manufacture
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