Label: CALAMINE- calamine 8% and zinc oxide 8% 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 March 17, 2022

If you are a consumer or patient please visit this version.

  • 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 2 years 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.

  • Good Neighbor Label

    GNPCal.jpg

  • Health Care Label

    HC

  • Quality Choice Label

    QCCal.jpg

  • Select Brand Label

    SB

  • Sun Mark Label

    SMCal.jpg

  • Premier Value

    PVCal.jpg

  • Fred's Calamine

    Freds

  • DDM Label

    DDM

  • Rite Aid Label

    RACal.jpg

  • Harris Teeter Label

    HT

  • Health Mart Label

    HMCal.jpg

  • Dollar Tree Label

    Dollar

  • Equate Label

    Equate CalamineEquate

  • 99 Cent Label

    99Cal.jpg

  • Top Care Label

    Top Care CalamineTCCal.jpg

  • Assured Label

    AssuredCal.jpg

  • INGREDIENTS AND APPEARANCE
    CALAMINE 
    calamine 8% and zinc oxide 8% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82645-900
    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
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CALCIUM HYDROXIDE (UNII: PF5DZW74VN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    BENTONITE (UNII: A3N5ZCN45C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82645-900-96177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/13/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/25/1998
    Labeler - Pharma Nobis, LLC (118564114)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114label(82645-900) , manufacture(82645-900) , analysis(82645-900) , pack(82645-900)