Label: WALGREENS CALAMINE SKIN PROTECTANT- ferric oxide red, 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 October 5, 2011

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  • Drug Facts


  • Active Ingredients

    Calamine 8%

    Zinc oxide 8%

  • Purpose

    Skin protectant
  • Use

    For the temporary relief of pain and itching associated with minor skin irritations.

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

  • Warnings

    For external use only

    When using this product do not get into eyes

    Stop use and ask a doctor if condition worsens or does not improve within 7 days

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    • shake well before using
    • apply with cotton as needed
  • Other information

    Preserve in tight containers, and avoid exposure to excessive heat.

  • Inactive ingredients

    bentonite magma, calcium hydroxide, glycerin, purified water

  • SPL UNCLASSIFIED SECTION

    Distributed by: Walgreen Co.,

    200 Wilmot Rd.,

    Deerfield, IL 60015-4616

    Quality Guaranteed

    100% Satisfaction Guaranteed with all Walgreens Products or Your Money Back.

    www.walgreens.com

  • Front Panel Display Walgreens Calamine Topical Suspension U.S.P. Skin Protectant 177ml (0363-4360-10)

    NDC 0363-4360-10

    Walgreens

    Calamine

    Topical Suspension U.S.P.

    Skin Protectant

    Poison Ivy, Oak,

    Sumac Dry Lotion

    SAFETY SEALED: DO NOT USE IF INNER SEAL IS BROKEN OR MISSING

    6 FL OZ (177 ml)


    Calamine

  • INGREDIENTS AND APPEARANCE
    WALGREENS CALAMINE  SKIN PROTECTANT
    ferric oxide red, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-4360
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED8 mL  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE8 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENTONITE (UNII: A3N5ZCN45C)  
    CALCIUM HYDROXIDE (UNII: PF5DZW74VN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-4360-10177 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/05/2011
    Labeler - Walgreen Company (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humco Holding Group, Inc.825672884manufacture
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