Label: CALAMINE- ferric oxide red lotion

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

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 December 8, 2022

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  • Active ingredient

    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: DZA Brands, LLC

    Salisbury, NC 28147/Scarborough, ME 04074

    For product questions or concerns

    contact us at 1-866-322-2439

    Made in the USA with US and foreign components

  • principal display panel

    NDC 55316-063-26

    healthy

    accents

    calamine lotion

    calamine topical suspension USP

    skin protectant

    • poison ivy
    • oak
    • sumac drying lotion

    Net 6 FL OZ (177mL)

    image description

  • INGREDIENTS AND APPEARANCE
    CALAMINE  
    ferric oxide red lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-063
    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)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55316-063-26177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/05/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/05/2008
    Labeler - DZB Brands, LLC (090322194)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(55316-063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(55316-063)
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