EARTH BEST DIAPER RELIEF (ZINC OXIDE) OINTMENT [THE HAIN CELESTIAL GROUP, INC]

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EARTH BEST DIAPER RELIEF (ZINC OXIDE) OINTMENT [THE HAIN CELESTIAL GROUP, INC]
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NDC 61995-4704-4
Set ID 276f36c4-8f03-6eef-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager The Hain Celestial Group, Inc
Generic Name
Product Class
Product Number
Application Number PART347
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  • ACTIVE INGREDIENT

    Zinc Oxide 19.0%

  • PURPOSE

    Skin Protectant

  • INDICATIONS & USAGE

    • 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 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

    Change wet diaper promptly. Clean diaper area and allow to dry. Apply generously with each diaper change and before bedtime.

  • INACTIVE INGREDIENT

    Helianthus Annuus (Sunflower) Seed Oil * ,Beeswax*, Glyceryl Dibehenate, Tribehenin, 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, Tocopheryl Acetate.

    * Certified Organic Ingredients

  • QUESTIONS

    Questions? Visit www.earthsbest.com or cal l877-527-6601

  • PRINCIPAL DISPLAY PANEL

    tube label


  • INGREDIENTS AND APPEARANCE
    EARTH BEST DIAPER RELIEF 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-4704
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE19 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHAMOMILE (UNII: FGL3685T2X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)  
    GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-4704-4113 g in 1 TUBE; Type 0: Not a Combination Product08/24/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/24/2011
    Labeler - The Hain Celestial Group, Inc (117115556)
    Registrant - The Hain Celestial Group, Inc. (014334364)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc081512382manufacture(61995-4704)
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