Label: CALAMINE- calamine and zinc oxide lotion

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

Drug Label Information

Updated October 27, 2023

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  • Active ingredient

    Calamine 8%,

    Zinc Oxide 8%

  • Purpose

    Skin protectant

  • Uses

    Dries the oozing and weeping of poison:

    • ivy
    • oak
    • sumac
  • Warnings

    • For external use only
    • Use only as directed.
  • When using this product

    do not get into eyes

  • Ask a doctor before using

    on children under 2 years of age.

  • Stop use and ask a doctor if

    • condition worsens
    • 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

    • 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
    adults and children 2 years and older3 to 4 times daily as needed for
    comfort
    children under 2 yearsConsult a doctor before use

  • Other information

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

  • Inactive ingredients

    bentonite magma, calcium hydroxide, carageenan, glycerin, microcrystalline cellulose, purified water and xanthan gum

  • Questions or comments?

    1-888-235-2466

  • SPL UNCLASSIFIED SECTION

    Walgreens Pharmacist Recommended.

    Our pharmacists recommend the Walgreens brand.

    DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015
    100% SATISFACTION GUARANTEED walgreens.com
    ©2023 Walgreen Co.

    W3ORG0923-F

    L0000728

    R0723

  • Container label

    NDC 0363-9410-97

    Walgreens

    Calamine

    Lotion
    CALAMINE TOPICAL SUSPENSION USP/

    SKIN PROTECTANT

    • Poison ivy, oak

    & sumac drying lotion

    6 FL OZ (177 mL)

    image001

  • INGREDIENTS AND APPEARANCE
    CALAMINE 
    calamine and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9410
    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)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    BENTONITE (UNII: A3N5ZCN45C)  
    CALCIUM HYDROXIDE (UNII: PF5DZW74VN)  
    WATER (UNII: 059QF0KO0R)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-9410-97177 mL in 1 BOTTLE; Type 0: Not a Combination Product10/16/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01610/16/2023
    Labeler - WALGREEN COMPANY (008965063)
    Registrant - BIONPHARMA INC. (079637826)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114manufacture(0363-9410)
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