Label: CALAMINE- ferric oxide red lotion

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

Drug Label Information

Updated February 4, 2026

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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

  • Questions?

    1-888-593-0593

  • Adverse reactions

    Distributed By:

    MAJOR ®PHARMACEUTICALS

    Indianapolis, IN 46268

    (800) 616-2471

    www.major-rugby.com

    Rev. 03/25 M-97 Re-order No. 014283

  • principal display panel

    NDC 0904-2533-21

    MAJOR ®

    Calamine Lotion

    Calamine Topical Suspension USP

    Calamine 8%, Zinc Oxide 8%

    Skin Protectant

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

    Shake well before using

    6 FL OZ (177 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    CALAMINE 
    ferric oxide red lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-2533
    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:0904-2533-21177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/07/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01601/07/2013
    Labeler - Major Pharmaceuticals (191427277)
    Registrant - Nice-Pak Products, LLC (119091520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nice-Pak Products, LLC119091514manufacture(0904-2533)
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