Label: CALAMINE- ferric oxide red lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 16, 2023

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  • Active ingredients

    Calamine 8%
    Zinc oxide 8%

  • Purpose

    Skin protectant

  • Use

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

  • 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 within a few days
  • Keep out of reach of children.

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

  • Directions

    • shake well before using
    • apply as needed
  • Other information

    store at 59⁰ - 86⁰F

  • Inactive ingredients

    bentonite magma, calcium hydroxide, glycerin, purified water

  • SPL UNCLASSIFIED SECTION

    Distributed by: Perrigo Direct, Inc.

    Peachtree City, GA 30269

    www.PerrigoDirect.com

    1-888-593-0593

    GoodSense® is a registered trademark of L. Perrigo Company.

  • Principal Panel Display

    GOODSENSE

    NDC 75981-063-30

    Calamine Lotion

    Calamine Topical Suspension USP

    Skin Protectant

    Poison Ivy, Oak, Sumac

    Drying Lotion

    6 FL OZ (177 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    CALAMINE  
    ferric oxide red lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75981-063
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED8 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE8 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENTONITE (UNII: A3N5ZCN45C)  
    CALCIUM HYDROXIDE (UNII: PF5DZW74VN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75981-063-30177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/1992
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01609/15/1992
    Labeler - Perrigo Direct, Inc. (076059836)
    Registrant - Vi-Jon, LLC (088520668)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(75981-063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(75981-063)
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