CALAMINE (FERRIC OXIDE RED) LOTION [WAKEFERN FOOD CORP]

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CALAMINE (FERRIC OXIDE RED) LOTION [WAKEFERN FOOD CORP]
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NDC 41190-063-30
Set ID 75d27726-68b5-4b2a-b374-03ae059ee5fc
Category HUMAN OTC DRUG LABEL
Packager Wakefern Food Corp
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

  • Adverse Reaction Section

    DISTRIBUTED BY

    WAKEFERN FOOD CORP.

    5000 RIVERSIDE DRIVE

    KEASBEY, NJ 08832

    063.001/063AA

  • Principal Display Panel

    ShopRite

    SKIN PROTECTANT

    CALAMINE

    LOTION

    CALAMINE TOPICAL SUSPENSION U.S.P.

    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:41190-063
    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:41190-063-30177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/1989
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/15/1989
    Labeler - Wakefern Food Corp (069722418)
    Registrant - Vi Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC790752542manufacture(41190-063)
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