CALAMINE (FERRIC OXIDE RED) LOTION [MAJOR PHARMACEUTICALS]

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CALAMINE (FERRIC OXIDE RED) LOTION [MAJOR PHARMACEUTICALS]
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NDC 0904-2533-21
Set ID c25be68d-834a-4959-8d47-01ec789406ba
Category HUMAN OTC DRUG LABEL
Packager Major Pharmaceuticals
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

  • Questions or comments?

    (800) 616-2471

  • Adverse reactions

    Distributed By:

    MAJOR PHARMACEUTICALS

    17177 N LAUREL PARK DRIVE, SUITE 233

    Livonia, MI 48152

    Re-Order No 014282  M-97

    Rev. 10/16

    063.001/063AA

  • principal display panel

    NDC 0904-2533-21

    MAJOR

    Calamine

    Lotion

    Calamine Topical Suspension USP

    Skin Protectant

    Poison Ivy, Oak, Sumac

    Drying Lotion

    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 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: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 FINALpart34701/07/2013
    Labeler - Major Pharmaceuticals (191427277)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(0904-2533)
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