Label: DIAPER RASH 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 February 11, 2016

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  • Active Ingredients

    Active Ingredients

    Zinc Oxide: 19%

  • Purpose

    Purpose

    Skin Protectant

  • Uses

    • Helps treat and prevent diaper rash
    • Protects chafed skin associated with diaper rash
    • Helps protect against wetness
  • Warnings

    For external use only.

    When using this product * avoid contact with eyes.

    Stop use and ask a doctor if * condition worsens * symptoms last more than 7 days or clear up and return again within a few days.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    * Change wet or soiled diaper promptly. * Cleanse the diaper area and allow to dry. * Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime exposure to wet diapers may be prolonged.

  • Inactive Ingredients

    Helianthus Annuus (Sunflower) Seed Oil (1), Beeswax (1), Glyceryl Dibehenate, Tribehenin, Aloe Barbadensis Leaf Juice (1), Glyceryl Behenate, Tocopheryl Acetate, Carthamus Tinctorius (Safflower) Seed Oil (1), Olea Europae (Olive) Fruite Oil (1), Simmondsia Chinensis (Jojoba) Seed Oil (1), Calendula Officialis Flower Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1)(1) Certified Organic Ingredient

  • Questions?

    Questions? Visit giggle.com or call 800-495-8577

  • Package label principal display panel

    Diaper Rash Cream Label

  • INGREDIENTS AND APPEARANCE
    DIAPER RASH CREAM 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70306-1851
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE19 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    JOJOBA OIL (UNII: 724GKU717M)  
    GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)  
    CHAMOMILE (UNII: FGL3685T2X)  
    Product Characteristics
    Colorwhite (Off-white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70306-1851-4118 mL in 1 TUBE; Type 0: Not a Combination Product03/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/01/2016
    Labeler - giggle (194045402)
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