CALAMINE (FERRIC OXIDE RED) LOTION [TOPCO ASSOCIATES LLC]

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CALAMINE (FERRIC OXIDE RED) LOTION [TOPCO ASSOCIATES LLC]
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NDC 36800-063-26, 36800-063-30, 36800-063-34
Set ID 2b32e720-ac71-4d60-bc06-e28a00f8a450
Category HUMAN OTC DRUG LABEL
Packager Topco Associates 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

  • SPL UNCLASSIFIED SECTION

    DIST.BY TOPCO ASSOCIATES LLC

    ELK GROVE VILLAGE, IL 60007

    1-888-423-0139  TOPCO VIJ 712

    topcare@topco.com

    063.001/063AA

  • principal display panel

    NDC 36800-063-30

    TOPCARE 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:36800-063
    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:36800-063-30177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/1991
    2NDC:36800-063-26237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/199105/28/2021
    3NDC:36800-063-34237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/199105/28/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/15/1991
    Labeler - Topco Associates LLC (006935977)
    Registrant - Vi Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC790752542manufacture(36800-063)
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