Label: TOPCARE CALAMINE- calamine 8% and zinc oxide 8% lotion lotion

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 18, 2023

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  • ACTIVE INGREDIENT

    Calamine 8% and Zinc Oxide 8%

  • PURPOSE

    Skin protectant

  • INDICATIONS & USAGE

    dries the oozing and weeping o poison ivy, poison oak, and poison sumac.

  • WARNINGS

    For external use only. Use only as directed.

    Avoid contact with eyes and mucous membranes.

    Ask a doctor before using on chilren 2 years of age.

  • KEEP OUT OF REACH OF CHILDREN

    In case of accidental ingestion, seek professional assistance or contact a Poison Control center immediately.

  • DOSAGE & ADMINISTRATION

    Adults and chidren 2 years of age and older: shake well before using. Cleanse the skin with soap and water and let it dry befroe each use. Apply lotion to the affected area using a cotton or soft cloth, as often as needed for comfort.

    Children under 2 years of age: Consult a doctor before use.

  • INACTIVE INGREDIENT

    Bentonite magma, calcium hydroxide, glycerin, purified water.

  • PRINCIPAL DISPLAY PANEL

    Top Care CalamineTCCal.jpgcl

  • INGREDIENTS AND APPEARANCE
    TOPCARE CALAMINE 
    calamine 8% and zinc oxide 8% lotion lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-702
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION160 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENTONITE (UNII: A3N5ZCN45C)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    CALCIUM HYDROXIDE (UNII: PF5DZW74VN)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-702-96177 mL in 1 CONTAINER; Type 0: Not a Combination Product07/16/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01607/16/2019
    Labeler - TOPCO ASSOCIATES LLC (006935977)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114analysis(36800-702) , manufacture(36800-702) , label(36800-702) , pack(36800-702)
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