Label: DIAPERDERM DIAPER RASH- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 6, 2023

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  • Drug Facts

  • Active Ingredient

    Zinc Oxide 5%

    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,

    avoid contact with eyes.

    Stop use and ask a doctor

    if condition worsens or symptoms last more than 7 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 paste liberally as often as necessary, with each diaper change, especially at bedtime or when exposure to wet diaper may be prolonged
  • Inactive Ingredients

    lanolin, petrolatum, vitamin A, vitamin D3

  • Package Labeling:

    Box

  • INGREDIENTS AND APPEARANCE
    DIAPERDERM DIAPER RASH 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80651-093
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN (UNII: 7EV65EAW6H)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    VITAMIN A (UNII: 81G40H8B0T)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80651-093-00236 mL in 1 JAR; Type 0: Not a Combination Product09/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01609/30/2020
    Labeler - Diaperderm Inc (046541026)
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