Label: CALAMINE- calamine and zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 19, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Calamine 8% and Zinc Oxide 8%

  • Purpose

    Skin protectant

  • Uses

    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 6 months of age.

  • When using this product

    Discontinue use if condition worsens or does not improve within 7 days and consult a doctor.

  • Keep out of reach of children

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

  • Directions

    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

  • Other information

    Store at room temperature 15-30C (59-86F)

  • Inactive ingredients

    Bentonite magma, calcium hydroxide, glycerin, purified water.

  • label

    Equate Calaminelabel

  • INGREDIENTS AND APPEARANCE
    CALAMINE 
    calamine and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-413
    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
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    BENTONITE (UNII: A3N5ZCN45C)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CALCIUM HYDROXIDE (UNII: PF5DZW74VN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-413-96177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/30/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01612/30/2017
    Labeler - Wal-Mart Stores, Inc. (051957769)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114label(49035-413) , manufacture(49035-413) , analysis(49035-413) , pack(49035-413)
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