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Calamine (DZB Brands, LLC)

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LOTION .118 L in 1 BOTTLE, PLASTIC (55316-063-26) Label Information

Complete Calamine Information

  • ACTIVE INGREDIENT

    Active ingredients
    Calamine 8%
    Zinc Oxide 8%

    Purpose
    Skin protectant

  • INDICATIONS & USAGE

    Use dries the oozing and weeping of poison: ivy oak sumac

  • WARNINGS

    Warnings
    For external use only

    When using this product do not get into eyes

    Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again withing a few days

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions
    shake well before using
    apply as needed

  • STORAGE AND HANDLING

    Other information store at 59⁰ - 86⁰F

  • INACTIVE INGREDIENT

    Inactive ingredients bentonite magma, calcium hydroxide, glycerin, purified water

  • ADVERSE REACTIONS

    Distributed by: DZA Brands, LLC
    2110 Executive Drive
    Salisbury, NC 28147

    For product questions or concerns
    contact us at 1-866-322-2439
    Please include the UPC number and
    code from package

  • PRINCIPAL DISPLAY PANEL

    NDC 55316-063-26
    healthy
    accents
    calamine topical suspension USP
    calamine lotin
    skin protectant
    poison ivy, oak + sumac
    drying lotion
    4 FL OZ (118 mL)
    image of principal display panel


  • INGREDIENTS AND APPEARANCE
    CALAMINE  
    ferric oxide red lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55316-063
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED .8 kg  in 100 L
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE .8 kg  in 100 L
    Inactive Ingredients
    Ingredient Name Strength
    CALCIUM HYDROXIDE (UNII: PF5DZW74VN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55316-063-26 .118 L in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part346 02/05/2008
    Labeler - DZB Brands, LLC (090322194)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 790752542 manufacture