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 September 19, 2022

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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

  • SPL UNCLASSIFIED SECTION

    Distributed by: Perrigo Direct, Inc

    Peachtree City, GA 30269

    www.PerrigoDirect.com

    1-866-593-0593

    GoodSense is a registered trademark of L. Perrigo Company.

  • principal display panel

    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:50804-063
    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:50804-063-30177 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 finalpart34709/15/1992
    Labeler - Perrigo Direct, Inc. (076059836)
    Registrant - Vi Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC790752542manufacture(50804-063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC088520668manufacture(50804-063)
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