Label: WALGREENS ZINC OXIDE- zinc oxide ointment

  • 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 1, 2018

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  • ACTIVE INGREDIENT

    Active Ingredient                                           Purpose

    Zinc oxide 40%.............................................Skin protectant

  • PURPOSE

    Uses

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

    Warnings

    For external use only.

    This product contains trace amounts of naturally occurring metals. Do not use on broken skin

  • WHEN USING

    When using this product

    • do not get into eyes
  • STOP USE

    Stop use and ask a doctor if

    • condition worsens
    • symtoms last more than 7 days or clear up and occur again within a few days.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

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

  • INDICATIONS & USAGE

    Directions

    • change wet or soiled diapers promptly
    • clean the diaper area
    • allow to dry
    • apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
  • STORAGE AND HANDLING

    Other Information

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

  • INACTIVE INGREDIENT

    Inactive ingredients

    butylated hydroxytoluene, lanolin, lavender oil, liquid paraffin, methylparaben, petrolatum, polysorbate 60, talc, tocopherol acetate

  • DOSAGE & ADMINISTRATION

    Distributed by:

    Walgreen Co.

    299 Wilmot Rd.,

    Deerfield, IL 60015 USA

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    353436

  • INGREDIENTS AND APPEARANCE
    WALGREENS ZINC OXIDE 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-6771
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION40 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    LANOLIN (UNII: 7EV65EAW6H)  
    TALC (UNII: 7SEV7J4R1U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-6771-571 in 1 CARTON10/13/2016
    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 finalpart34705/28/2014
    Labeler - Walgreen Company (008965063)
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