Label: CALAMINE- calamine and zinc oxide lotion

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

Drug Label Information

Updated December 28, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Calamine 8% and Zinc Oxide 8%

  • Uses

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

  • Purpose

    Skin protectant

  • Warnings

    For external use only. Use only as directed.

    Avoid contact with eyes and mucous membranes.

    Ask a doctor before using on chilren under 2 years of age.

  • Stop use and ask a doctor if

    condition worsens, does not improve or if symptoms last 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 (1-800-222-1222) right away.

  • 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, not more than 3 to 4 times daily as needed for comfort.

    Children under 2 years of age: Consult a doctor before use

  • Other information

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

  • Inactive ingredients

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

  • Questions

    Questions or Comments? 1-833-551-0932

  • label

    Freskaro Calamine 5-16-23

  • INGREDIENTS AND APPEARANCE
    CALAMINE 
    calamine and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82645-418
    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 CATION - UNII:13S1S8SF37) ZINC CATION80 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENTONITE (UNII: A3N5ZCN45C)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CALCIUM HYDROXIDE (UNII: PF5DZW74VN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82645-418-96177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/16/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01605/16/2023
    Labeler - Pharma Nobis, LLC (118564114)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114label(82645-418) , manufacture(82645-418) , analysis(82645-418) , pack(82645-418)
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