Label: DESERT ESSENCE DONT BE RASH DIAPER CREAM- 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 May 19, 2014

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  • Active Ingredient

    Zinc Oxide 12%

  • Purpose:

    Skin Protectant

  • Uses:

    • Helps treat and prevent diaper rash

    • Helps seal out wetness

    • Protects chafed skin due to diaper rash

  • Warnings:

    For external use only

  • WARNINGS

    When using this product, do not get into eyes

  • WARNINGS

    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

    Keep out of reach of children. If swallowed, get medical help or contact a physician.

  • Directions for Use:

    • Apply to clean, dry skin by massaging a thick layer on baby's bottom. 

  • Inactive Ingredients:

    Ricinus Communis (Castor) Seed Oil*, Lanolin, Beeswax (Cera Alba)*, Silica

    * Certified Organic

  • Principal Display Panel

    Image Componentscomponent artwork

  • INGREDIENTS AND APPEARANCE
    DESERT ESSENCE DONT BE RASH DIAPER CREAM 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0338
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    LANOLIN (UNII: 7EV65EAW6H)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51514-0338-189 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/09/2011
    Labeler - Autumn Harp, Inc. (064187883)
    Establishment
    NameAddressID/FEIBusiness Operations
    Autumn Harp, Inc.064187883manufacture(51514-0338)
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