Label: CALAMINE- ferric oxide red lotion

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

Drug Label Information

Updated February 26, 2025

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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 - 86⁰ F

  • Inactive ingredients

    bentonite magma, calcium hydroxide, glycerin, purified water

  • ADVERSE REACTION

    Distributed by CMDA, Inc.

    Novi, MI 48375

    www.qualitychoice.com

    Questions: 800-935-2362

    SATISFACTION GUARANTEED

    100% QC

  • PRINCIPAL DISPLAY PANEL

    NDC 83324-248-06

    QC 

    QUALITY CHOICE

    Calamine

    Lotion

    Calamine Topical Suspension USP

    Skin Protectant

    Dries the Oozing and Weeping of Poison:

    Ivy, Oak & Sumac

    6 FL OZ (177 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    CALAMINE 
    ferric oxide red lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83324-248
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED80 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE80 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:83324-248-06177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/26/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01602/26/2025
    Labeler - CDMA (011920774)
    Registrant - Consumer Product Partners, LLC (119091520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091514manufacture(83324-248)
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