Label: DIAPER- 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 December 3, 2019

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  • ACTIVE INGREDIENT

    Active Ingredients                                                               Purpose

    Zinc Oxide 12.8%..............................................................Skin Protectant

  • Purpose

    Skin Protectant

  • Warnings

    FOR EXTERNAL USE ONLY

  • When using this product

    When using this product keep out of eyes.

  • Stop use and ask a doctor if

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

  • Keep out of reach of children

    Keep out of reach of children.

  • Other Information

    protect this product from excessive heat and direct sun

  • Inactive Ingredients

    Petrolatum, corn starch, anhydrous lanolin, stearyl alcohol, beeswax, camellia sinensis leaf extract, tocopheryl acetate, sunflower seed extract, sorbitan oleate, bisabolol, cholesterol

  • Indications

    Uses

    Help heal and prevent diaper rash

    Protects chafed skin due to diaper rash and helps protect wetness

  • Do Not Use

    Discontinue use if irritation occurs.

  • Ask a doctor

    Ask a doctor if condition worsens

  • Directions

    change wet and soiled diapers promptly

    cleanse the diaper area

    allow to dry

    apply ointment liberally as often as necessary with each diaper change and anytime when exposure to wet diapers may be prolonged

  • dosage

    apply ointment liberally as often as necessary with each diaper change and anytime when exposure to wet diapers may be prolonged

  • image of label

    image of label

  • INGREDIENTS AND APPEARANCE
    DIAPER 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71969-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION21.76 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    LANOLIN (UNII: 7EV65EAW6H)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
    TOCOL ACETATE (UNII: 37Z972M0N0)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI)  
    BISABOLOL OXIDE A (UNII: 16AE65F94Y)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71969-111-01170 g in 1 JAR; Type 0: Not a Combination Product03/08/2018
    2NDC:71969-111-021 in 1 PACKAGE04/09/2018
    257 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/08/2018
    Labeler - Medek Laboratories Inc. (080332132)
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