Label: BABY MAGIC MEDICATED PATTY CAKE- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 January 1, 2012

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  • ACTIVE INGREDIENT

    Active Ingredient : Zinc Oxide (28%)


  • PURPOSE

    Uses: Helps treat and prevent diaper rash. Protects minor skin irritation associated with diaper rash and helps protect from wetness.


  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed ,get medical help or contact a  Poison Control Center immediately.


  • 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 as often as necessary, with each diaper change specially at bedtime or anytime when exposure to wet diapers may be prolonged. Swipe disposable cotton round applicator across Medicated Patty Cake.

    Apply baby powder on baby's bottom and other areas that can use powder and are susceptible to irritating friction. For sanitation purpose, never touch a cotton round applicator that has been on the baby's bottom back  onto the powder.

    Dispose of cotton round applicator after each use.


  • INACTIVE INGREDIENT

    Allantoin ,Beeswax, Benzoic Acid, BHT, C12-15 Alkyl Benzoate, Copermicia Cerifera (Carnauba Wax) , Euphorbia Cerifera (Candellila) Wax, Fragrance , Glycereth-2 Cocoate , Hexyl Carprate , Lauryl Lysine , Nylon-12 , Ozokerite Wax, PEG-40  Stearate, Phenyl Trimethicone, Polymethylmethacrylate, Silica, Stearyl Alcohol, Titanium Dioxide, Tocopheryl  Acetate


  • PRINCIPAL DISPLAY PANEL

    Image of Carton

  • DOSAGE & ADMINISTRATION

    Enter section text here

  • INGREDIENTS AND APPEARANCE
    BABY MAGIC MEDICATED PATTY CAKE 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45765-5100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide2.75 g  in 11 g
    Inactive Ingredients
    Ingredient NameStrength
    Allantoin (UNII: 344S277G0Z)  
    Benzoic Acid (UNII: 8SKN0B0MIM)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)  
    HEXYL DECANOATE (UNII: D2D42X538B)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    NYLON-12 (UNII: 446U8J075B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45765-5100-011 g in 1 TRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34701/01/2012
    Labeler - Naterra International INC. (879056786)
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