Label: MAXIMUM STRENGTH DIAPER RASH- zinc oxide cream

  • 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 September 4, 2014

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  • Active ingredient

    Zinc Oxide, 40.0%

  • Purpose

    Skin protectant

  • Uses

    •
    helps treat and prevent diaper rash
    •
    protects chafed skin due to diaper rash and helps seal out wetness
  • Warnings

    For external use only.

  • When using this product

    •
    do not get into eyes
  • 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.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    •
    change wet and soiled diapers promptly
    •
    cleanse the diaper area
    •
    allow to dry
    •
    apply cream liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged
  • Other information

    store at 20° to 25°C (68° to 77°F)

  • Inactive ingredients

    cod liver oil, talc, petrolatum, lanolin, water, methylparaben, fragrance, BHA

  • Questions or Comments?

    1-800-925-4733

  • Package/Label Principal Display Panel

    Well at Walgreens Zinc Oxide Ointment

    Skin Protectant

    •
    For external use only
    •
    Avoid contact with eyes

    NET WT 2 OZ (57 g)

    Walgreens Pharmacist Recommended‡

    ‡Walgreens Pharmacist Survey Study, November 2012.

    Walgreens Way to Well Commitment®
    Support local preventive wellness with Walgreens.
    With each purchase of Walgreens Brand Health & Wellness Product, 1¢ goes to Walgreens Way to Well Fund, up to $3 million annually.
    Visit Walgreens.com/waytowell

    DISTRIBUTED BY:
    WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015
    100% SATISFACTION GUARANTEED
    walgreens.com © 2014 Walgreen Co.
    MADE IN ISRAEL

    Carton Label

    Container Label

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH DIAPER RASH 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9160
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE40 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COD LIVER OIL (UNII: BBL281NWFG)  
    TALC (UNII: 7SEV7J4R1U)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    LANOLIN (UNII: 7EV65EAW6H)  
    WATER (UNII: 059QF0KO0R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-9160-111 in 1 CARTON
    157 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/01/2014
    Labeler - Walgreen Company (008965063)
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