Label: DIAPER CREAM- zinc oxide diaper cream 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 30, 2020

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  • OTC - ACTIVE INGREDIENT SECTION (SQZ TUBE)

    OTC Active Ingredients

  • OTC - PURPOSE SECTION (SQZ TUBE)

    OTC Purpose

  • OTC - KEEP OUT OF REACH OF CHILDREN

    OTC Keep Out Of Reach Of Children

  • ARTWORK - SQUEEZE TUBE

    ARTWORK SQZ TUBE

  • ARTWORK (UNIT CARTON)

    Artwork

  • INGREDIENTS AND APPEARANCE
    DIAPER CREAM 
    zinc oxide diaper cream ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62932-235
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WHITE WAX (UNII: 7G1J5DA97F)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .GAMMA.-TOCOPHEROL (UNII: 8EF1Z1238F)  
    .BETA.-TOCOPHEROL (UNII: 9U6A490501)  
    .DELTA.-TOCOPHEROL (UNII: JU84X1II0N)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62932-235-4556 g in 1 TUBE; Type 0: Not a Combination Product07/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35207/13/2020
    Labeler - Private Label Select Ltd CO (005415463)