Label: HARRIS TEETER CALAMINE- zinc oxide liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 20, 2023

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  • Harris Teeter Calamine Lotion

    Drug Facts

  • Active Ingredient

    Calamine 8%

  • Active Ingredient

    Zinc Oxide 8%

  • Purpose

    Skin Protectant

  • Uses

    Dries the oozing and weeping of 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 children

  • When using this product.

    Discontinue use if condition worsens, does not improve or if symptoms persist for more than 7 days, or clear up and occur again within a few 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 children 2 yrs. of age and older. Shake well before using. Cleanse the skin with soap and water and let dry before each use. Apply lotion to the affected area using cotton or soft cloth, as often as needed.
    • Children under 6 months of age: Consult a doctor before use.
  • Other Information

    store at room temperature 15o – 30oC (59o – 85oF)

  • Inactive Ingredients

    Avicel, Bentonite Magma, Calcium Hydroxide, Carrageenan, Glycerin, Purified Water, and Xanthan Gum.

  • Label

    image description

  • INGREDIENTS AND APPEARANCE
    HARRIS TEETER CALAMINE 
    zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69256-413
    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
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    BENTONITE (UNII: A3N5ZCN45C)  
    CALCIUM HYDROXIDE (UNII: PF5DZW74VN)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69256-413-96177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/26/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01610/26/2017
    Labeler - Harris Teeter, LLC. (048463103)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114manufacture(69256-413) , analysis(69256-413) , pack(69256-413) , label(69256-413)
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