BABY MAGIC MEDICATED PATTY CAKE - zinc oxide cream 
Naterra International INC.

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.

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Baby Magic Medicated Patty Cake

Active Ingredient : Zinc Oxide (28%)


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


Warnings; For external use only


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.


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


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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)

Revised: 1/2012
Document Id: fba075ec-06b1-4709-8e31-95bed7970c45
Set id: 99889e83-2583-49fb-ab17-5ec331a5c728
Version: 1
Effective Time: 20120101
 
Naterra International INC.