BABY SPECIALTY CREAM (ZINC OXIDE 12%) CREAM [BIOLOGICAL HEALTH GROUP CORPORATION]

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BABY SPECIALTY CREAM (ZINC OXIDE 12%) CREAM [BIOLOGICAL HEALTH GROUP CORPORATION]
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NDC 69711-009-06
Set ID 1923d661-9395-655b-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Biological Health Group Corporation
Generic Name
Product Class
Product Number
Application Number PART347
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  • Active Ingredient

    Zinc Oxide 12%

  • Purpose

    Skin Protectant

  • Uses

    • Brings temporary, quick and effective relief for minor skin irritations due to diaper rash. Protects from dampness.
  • Warnings

    For external use only.

    When using this product

    • do not get into eyes.

    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. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.
  • Inactive Ingredients

    Purified Water, Glycerin, Calendula, Camomille, Evening Primrose Oil, Rose Hips Extract, Carrot Seed Oil, Beeswax, Vitamin E, Grapefruit Seed Extract.

  • PRINCIPAL DISPLAY PANEL

    Box

    Label

  • Other Information

    Store at room temperature.

  • Questions?

    Call toll-free for US & Canada 844-881-2882 or visit www.deserving-health.com

  • INGREDIENTS AND APPEARANCE
    BABY SPECIALTY CREAM 
    zinc oxide 12% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69711-009
    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
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CHAMOMILE (UNII: FGL3685T2X)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    CARROT SEED OIL (UNII: 595AO13F11)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    CITRUS PARADISI SEED (UNII: 12F08874Y7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69711-009-061 in 1 CARTON06/18/2015
    160 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/18/2015
    Labeler - Biological Health Group Corporation (079767886)
    Registrant - Biological Health Group Corporation (079767886)
    Establishment
    NameAddressID/FEIBusiness Operations
    Deserving Health International Corp202617023manufacture(69711-009)
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