CALAMINE (FERRIC OXIDE RED) LOTION [DOLGENCORP, LLC]

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CALAMINE (FERRIC OXIDE RED) LOTION [DOLGENCORP, LLC]
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NDC 55910-063-30
Set ID c38c77fd-abbf-4c87-a9c0-a0e21ed3f97d
Category HUMAN OTC DRUG LABEL
Packager Dolgencorp, LLC
Generic Name
Product Class
Product Number
Application Number PART346
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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 wthin 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

    Visit us at: Rexall.com

    or call 1-866-4REXALL

    DISTRIBUTED BY DOLGENCORP, LLC

    100 MISSION RIDGE

    GOODLETTSVILLE, TN 37072 USA

    063.001/063AA

  • principal display panel

    Since 1903
    REXALL

    Calamine Lotion
    Calamine Topical Suspension USP
    • Poison ivy, oak and sumac drying lotion
    • Skin protectant

    6 FL OZ (177 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    CALAMINE  
    ferric oxide red lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-063
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-063-30177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/13/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/13/2009
    Labeler - Dolgencorp, LLC (068331990)
    Registrant - Vi Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC790752542manufacture(55910-063)
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