CALAMINE (FERRIC OXIDE RED) LOTION [VI JON]

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CALAMINE (FERRIC OXIDE RED) LOTION [VI JON]
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NDC 0869-0063-26, 0869-0063-30, 0869-0063-34
Set ID 40a868a8-84a5-4c61-bf00-2b3477578c2e
Category HUMAN OTC DRUG LABEL
Packager Vi Jon, LLC
Generic Name
Product Class
Product Number
Application Number PART347
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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

    Manufactured by Vi-Jon, LLC

    St. Louis, MO 63114

    Questions or Comments?  1-888-593-0593

    Made in the USA with US and foreign parts

  • principal display panel

    NDC 0869-0063-30

    swan

    Calamine

    Lotion

    • Calamine Topical Suspension USP
    • Skin Protectant
    • Poison Ivy, Oak, Sumac Drying Lotion

    6 FL OZ (177 mL)

    image description

  • PRINCIPAL DISPLAY PANEL

    Mountain Falls 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:0869-0063
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0869-0063-30177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/1998
    2NDC:0869-0063-26118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/1998
    3NDC:0869-0063-34237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/1998
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/15/1989
    Labeler - Vi Jon, LLC (790752542)
    Registrant - Vi Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC790752542manufacture(0869-0063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(0869-0063)
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