BABY MAGIC DIAPER RX  - 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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Active Ingredient : Zinc Oxide (28%)


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


Warnings; For external use only


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


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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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)

Revised: 2/2011
Document Id: 95dba6f2-e2e4-4109-8146-1bf624d67d0f
Set id: 92257e81-4b7f-440b-a714-1aeb81d5c127
Version: 1
Effective Time: 20110214
 
Naterra International INC.