Label: CALAMINE - ferric oxide red and zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 07/15

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  • Active ingredents

    Calamine 8%
    Zinc oxide 8%

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  • Purpose

    Skin Protectant

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  • Use

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

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  • Warnings

    For external use only

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  • When using this product

    Do not get into eyes

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  • Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days
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  • Keep out of reach of children

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

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  • Directions

    • shake well before using • apply as needed

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  • Other information

    store at 59⁰ - 86⁰ F

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  • Inactive ingredients

    bentonite magma, calcium hydroxide, glycerin, purified water

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  • Questions

    Call 1-822-910-6874

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  • Adverse Reaction Section

    Distributed by Target Corporation

    Minneapolis, MN 55403

    Made in U.S.A. with U.S.

    and foreign omponents

    2015 Target Brands, Inc

    Shop Target.com

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  • Package Label

    NDC 11673-063-30

    calamine

    lotion

    calamine topical

    suspension USP

    skin

    protectant

    poison ivy, poison oak

    and sumac drying lotion

    6 FL OZ (177 mL)

    image description

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  • INGREDIENTS AND APPEARANCE
    CALAMINE  
    ferric oxide red lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-063
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED 8 g  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 8 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENTONITE (UNII: A3N5ZCN45C)  
    CALCIUM HYDROXIDE (UNII: PF5DZW74VN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11673-063-30 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 11/26/1997
    Labeler - Target Corporation (006961700)
    Registrant - Vi Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi Jon 088520668 manufacture(11673-063)
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