Label: ASSURED CALAMINE- calamine 8% and zinc oxide 8% lotion

  • NDC Code(s): 33992-4130-6
  • Packager: Greenbriar International
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2023

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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

    Bentonite magma, calcium hydroxide, glycerin, purified water.

  • assured calamine

    assured calamine.jpg

  • INGREDIENTS AND APPEARANCE
    ASSURED CALAMINE 
    calamine 8% and zinc oxide 8% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-4130
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    CALCIUM HYDROXIDE (UNII: PF5DZW74VN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-4130-6177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01601/27/2020
    Labeler - Greenbriar International (610322518)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114label(33992-4130) , manufacture(33992-4130) , analysis(33992-4130) , pack(33992-4130)
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