CALAMINE (FERRIC OXIDE RED) LOTION [DZB BRANDS, LLC]

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CALAMINE (FERRIC OXIDE RED) LOTION [DZB BRANDS, LLC]
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NDC 55316-063-26
Set ID 8c1b0675-bbe9-42a4-80f1-3efff1d6346c
Category HUMAN OTC DRUG LABEL
Packager DZB Brands, LLC
Generic Name
Product Class
Product Number
Application Number PART346
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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)
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