Label: BABY MAGIC DIAPER RX - zinc oxide cream

  • NDC Code(s): 45765-5130-0
  • Packager: Naterra International INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/11

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  • ACTIVE INGREDIENT

    Active Ingredient : Zinc Oxide (28%)


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  • PURPOSE

    Uses: Helps treat and prevent diaper rash , chaged skin and minor skin irritation by protecting and ealing out wetness.


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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingestion, seek professional assistance or cntact a Poison Control Center right away


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  • WARNINGS

    Warnings; For external use only


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  • INDICATIONS & USAGE

    Direction

    Change wet and soiled diapers promptly; cleanse diaper area and allow to dry

    Apply product liberally with each diaper change and expecially at bedtime when exposure to wet diapers may be prolonged


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  • INACTIVE INGREDIENT

    Allantoin ,Ascorbyl Palmitate , Beeswax , BHA , Carthamus Tintorius (Safflower) Seed Oil , Fragrance , Glycyrrhiza Glabra (Licorice) Root Extract ,

    Persea Gratissima (Avocado) Oil , Petrolatum , Retinyl Palmitate , Tocopherol , Tocopheryl Acetate.


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  • DOSAGE & ADMINISTRATION

    Enter section text here

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  • INGREDIENTS AND APPEARANCE
    BABY MAGIC DIAPER RX  
    zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:45765-5130
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Zinc Oxide (Zinc Oxide ) Zinc Oxide 23.8 g  in 85 g
    Inactive Ingredients
    Ingredient Name Strength
    Allantoin  
    Ascorbyl Palmitate  
    YELLOW WAX  
    BUTYLATED HYDROXYANISOLE  
    SAFFLOWER OIL  
    GLYCYRRHIZA GLABRA  
    AVOCADO OIL  
    Petrolatum  
    VITAMIN A PALMITATE  
    Tocopherol  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:45765-5130-0 85 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part347 04/30/2010
    Labeler - Naterra International INC. (879056786)
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