CALAMINE (FERRIC OXIDE RED) LOTION [FOODHOLD U.S.A. LLC]

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  • CALAMINE (FERRIC OXIDE RED) LOTION [FOODHOLD U.S.A. LLC]

CALAMINE (FERRIC OXIDE RED) LOTION [FOODHOLD U.S.A. LLC]
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NDC 41520-063-30
Set ID 261e4092-c986-488e-b8cf-e754a6403af7
Category HUMAN OTC DRUG LABEL
Packager FOODHOLD U.S.A. LLC
Generic Name
Product Class
Product Number
Application Number PART347
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  • Active ingredents

    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 Section

    DISTRIBUTED BY FOODHOLD U.S.A., LLC

    LANDOVER, MD 20785

    2016 S&S BRANDS LLC

    QUALITY GUARANTEED OR YOUR MONEY BACK

    063.000/063AA

  • principal display panel

    CAREONE

    Calamine

    Lotion

    CALAMINE TOPICAL

    SUSPENSION USP

    Skin Protectant

    CALAMINE 8%

    ZINC OXIDE 8%

    POISON IVY, OAK, SUMACK

    DRYING LOTION

    OUR PHARMACISTS RECOMMEND

    6 FL OZ (177 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    CALAMINE  
    ferric oxide red lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-063
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED8 g  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:41520-063-30177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/06/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/06/2013
    Labeler - FOODHOLD U.S.A. LLC (809183973)
    Registrant - Vi Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon088520668manufacture(41520-063)
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