WALGREENS MOISTURE BARRIER (MENTHOL, AND ZINC OXIDE) CREAM [WALGREEN COMPANY]

WALGREENS MOISTURE BARRIER (MENTHOL, AND ZINC OXIDE) CREAM [WALGREEN COMPANY]
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NDC 0363-3680-04
Set ID a6db6f13-4e02-47dc-aef6-a804506c3d8b
Category HUMAN OTC DRUG LABEL
Packager Walgreen Company
Generic Name
Product Class
Product Number
Application Number PART347
  • ACTIVE INGREDIENT

    Active ingredients                                                        Purpose

    Menthol 0.44%......................................................... External analgesic/ Anti-itch

    Zinc Oxide 20.6%..................................................... Skin protectant/ Anorectal astringent

  • PURPOSE

    Uses

    A moisture barrier that prevents & helps heal skin irritations from:

    • urine
    • diarrhea
    • perspiration
    • fistula drainage
    • feeding tube site leakage
    • wound drainage (peri-wound skin)
    • minor burns
    • cuts
    • scrapes
    • itching
  • WARNINGS

    Warnings:

    For external use only

    • Not for deep or puncture wounds
    • Avoid contact with eyes

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children

    • In case of accidental ingestion contact a physican or poison control center immediately
    • If condition worsens or does not improve within 7 days, consult a doctor
  • INDICATIONS & USAGE

    Directions

    Cleanse skin gently with mild skin cleanser. Pat dry or allow to air dry. Apply a thin layer of the ointment to irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection.

  • STORAGE AND HANDLING

    Other information

    Store between 15°-30° (59°-86°F)

  • INACTIVE INGREDIENT

    Inactive ingredients

    butylated hydroxytoluene, calamine, cetyl esters, glycerin, lanolin, phenol sodium, bicarbonate, thymol, white petrolatum

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    WALGREEN CO.

    200 WILMOT RD.

    DEERFIELD, IL 60015

    MADE IN KOREA

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    WALGREENS MOISTURE BARRIER 
    menthol, and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-3680
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.44 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION20.6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LANOLIN (UNII: 7EV65EAW6H)  
    PHENOL (UNII: 339NCG44TV)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    THYMOL (UNII: 3J50XA376E)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-3680-041 in 1 PACKAGE10/04/2016
    1113 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/16/2015
    Labeler - Walgreen Company (008965063)