Label: BABY MAGIC DIAPER RX- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL

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 February 14, 2011

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  • ACTIVE INGREDIENT

    Active Ingredient : Zinc Oxide (28%)


  • PURPOSE

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


  • 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


  • WARNINGS

    Warnings; For external use only


  • 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


  • 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.


  • PRINCIPAL DISPLAY PANEL

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  • DOSAGE & ADMINISTRATION

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  • INGREDIENTS AND APPEARANCE
    BABY MAGIC DIAPER RX  
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45765-5130
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide23.8 g  in 85 g
    Inactive Ingredients
    Ingredient NameStrength
    Allantoin (UNII: 344S277G0Z)  
    Ascorbyl Palmitate (UNII: QN83US2B0N)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    Petrolatum (UNII: 4T6H12BN9U)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    Tocopherol (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45765-5130-085 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34704/30/2010
    Labeler - Naterra International INC. (879056786)
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