Label: CALAMINE- calamine and zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 16, 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 finalpart34705/16/2023
    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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