Label: PREMIERE VALUE CALAMINE- calamine 8% and zinc oxide 8% lotion

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

Drug Label Information

Updated December 20, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • active Ingredients

    Calamine 8%

    Zinc Oxide 8%

  • Purpose

    Skin Protectant

    Skin Protectant

  • Uses

    Dries the oozing and weeping of poison ivy, poison oak, and poison sumac and other skin irritations.

  • Warnings

    For external use only. Use only as directed.

    Avoid contat with eyes and moucous membranes.

  • Ask a doctor

    before using on children under 6 years of age.

    Stop use and ask a doctor if

    • Condition worsens
    • Symptoms last for more than 7  days or clear up and occur again within a few days.
  • 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 6 mo. of age and older: Shake well before using. Cleanse the skin with soap and water. Let dry before each use. Apply lotion to the affected area using cotton or soft cloth, as often as needed for comfort.

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

  • Other information

    Store at room temperature 15-30C (59-86F)

  • Inactive Ingredients

    Bentonite Magma, Calcium Hydroxide, Glycerin, and Purified Water.

  • Questions or Comments?

  • Label

    PV Calamine

  • INGREDIENTS AND APPEARANCE
    PREMIERE VALUE CALAMINE 
    calamine 8% and zinc oxide 8% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-413
    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
    BENTONITE (UNII: A3N5ZCN45C)  
    CALCIUM HYDRIDE (UNII: WY779SQ0XW)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-413-96177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/27/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01601/01/2008
    Labeler - Chain Drug Consortium (101668460)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114manufacture(68016-413) , analysis(68016-413) , pack(68016-413) , label(68016-413)
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