FREDS CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [FRED'S, INC.]

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FREDS CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [FRED'S, INC.]
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NDC 55315-413-96
Set ID 5df48f74-ea90-9a01-e053-2a91aa0a7d3b
Category HUMAN OTC DRUG LABEL
Packager Fred's, Inc.
Generic Name
Product Class
Product Number
Application Number PART347
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Calamine 8% and Zinc Oxide 8%

  • Purpose

    Skin protectant

  • Uses

    dries the oozing and weeping o poison ivy, poison oak, and poison sumac.

  • Warnings

    For external use only. Use only as directed.

    Avoid contact with eyes and mucous membranes.

    Ask a doctor before using on chilren 6 months of age.

  • When using this product

    Discontinue use if condition worsens or does not improve within 7 days and consult a doctor.

  • Keep out of reach of children

    In case of accidental ingestion, seek professional assistance or contact a Poison Control center immediately.

  • Directions

    Adults and chidren 2 years of age and older: shake well before using. Cleanse the skin with soap and water and let it dry befroe each use. Apply lotion to the affected area using a cotton or soft cloth, as often as needed for comfort.

    Children under 6 months of age: Consult a doctor before use.

  • Other information

    Store at room temperature 13-30C (50-86F)

  • Inactive ingredients

    Avicel, bentonite magma, calcium hydroxide, carrageenan, glycerin, purified water, and xanthan gum.

  • Label

    Label

  • INGREDIENTS AND APPEARANCE
    FREDS CALAMINE 
    calamine 8% and zinc oxide 8% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-413
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION160 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    BENTONITE (UNII: A3N5ZCN45C)  
    CALCIUM HYDROXIDE (UNII: PF5DZW74VN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55315-413-96177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/13/201703/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/25/199803/31/2024
    Labeler - Fred's, Inc. (005866116)
    Registrant - Humco Holding Group, Inc. (825672884)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humco Holding Group, Inc.825672884label(55315-413) , manufacture(55315-413) , analysis(55315-413) , pack(55315-413)
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