Label: GN KIDS ECZEMA- oatmeal cream

  • 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 August 13, 2012

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  • ACTIVE INGREDIENT

    COLLOIDAL OATMEAL

  • KEEP OUT OF REACH OF CHILDREN

    Keep Out Of Reach Of Children.
    If swallowed,get medical help or contact a Poison Control Center immediately.
  • PURPOSE

    Eczema Cream. For external use only.

  • INDICATIONS & USAGE

    Eczema cream, apply to affected area.

  • DOSAGE & ADMINISTRATION

    Topical cream. Apply as needed to affected areas.

  • WARNINGS

    For External use only. When using this product do not get into eyes.

    If pregnant or breastfeeding, ask a professional before use.

    Stop use and ask doctor if conditions worsen, symptoms last more than 7days or clear up and occur again in a few days.

  • INACTIVE INGREDIENT

    Water,Theobroma Oil, Olea Europaea Fruit Oil, Vitellaria Paradoxa, Simmondsia Chimensis Seed Oil, D-Alpha Tocopheryl Acetate,Vanilla Planifolia tincture, Allantoin, Sodium Benzoate, Potassium Sorbate, Cetyl Alcohol, Capryllic/Capric Triglyceride,Cetearyl Glucoside, Cetostearyl Alcohol, Bisabolol, Sclerotium Gum.

  • PRINCIPAL DISPLAY PANEL

    image of box image of box

  • INGREDIENTS AND APPEARANCE
    GN KIDS ECZEMA  
    oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42387-123
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL25 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SHEANUT OIL (UNII: O88E196QRF)  
    JOJOBA OIL (UNII: 724GKU717M)  
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)  
    VANILLA (UNII: Q74T35078H)  
    ALLANTOIN (UNII: 344S277G0Z)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42387-123-011 in 1 CARTON
    1NDC:42387-123-0073.7 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/24/2012
    Labeler - Grahams Natural Alternatives Pty Ltd (742235419)
    Registrant - COSMETIC MANUFACTURERS (AUST) PTY. LTD. (758742308)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSMETIC MANUFACTURERS (AUST) PTY. LTD.758742308manufacture(42387-123)
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