Label: AVALON ORGANICS BABY PROTECTIVE ZINC DIAPER BALM- 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 April 30, 2012

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  • ACTIVE INGREDIENT

    Zinc Oxide  21.0%

  • PURPOSE

    Natural Skin Protectant

  • INDICATIONS & USAGE

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

    When using this product keep out of eyes. Rinse with water to remove. Stop use and ask doctor if rash or irritation develops and lasts.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    • Apply liberally to clean,dry skin. Use as needed with diaper changes, especially at bedtime when exposure to wetness may be prolonged.
  • INACTIVE INGREDIENT

    Helianthus Annuus (Sunflower) Seed Oil *, Glyceryl  Dibehenate, Tribehenin, Beeswax*, Carthamus Tinctorius (Safflower) Oil* , Olea Europea (Olive) Fruit Oil *, Simmondsia Chinensis (Jojoba) Seed Oil*, Aloe Barbadensis Leaf Juice* , Calendula Officinalis Flower Extract* , Chamomilla Recutita (Matricaria) Flower Extract *, Glycerin *, Glyceryl Behenate, Retinyl Palmitate, Tocopheryl Acetate.

    * Certified Organic Ingredients
  • QUESTIONS

    Questions? Visit  www.avalonorganics.com or call 888-659-7730

  • PRINCIPAL DISPLAY PANEL


           
    image of front bottle label
                   
    image of back bottle label
           
  • INGREDIENTS AND APPEARANCE
    AVALON ORGANICS BABY PROTECTIVE ZINC DIAPER BALM 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-1110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide21 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-1110-385 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/18/2011
    Labeler - The Hain Celestial Group, Inc (858894996)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc858894996manufacture
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