Label: BABY SPECIALTY CREAM- zinc oxide 12% 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 June 22, 2015

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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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