DIAPER RASH CREAM- zinc oxide ointment 
Private Label Select Ltd CO

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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Principal Display

DIAPER RASH CREAM 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62932-156
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE14 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SUNFLOWER OIL (UNII: 3W1JG795YI)  
CASTOR OIL (UNII: D5340Y2I9G)  
SHEA BUTTER (UNII: K49155WL9Y)  
COCONUT OIL (UNII: Q9L0O73W7L)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
JOJOBA OIL (UNII: 724GKU717M)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62932-156-2089 g in 1 TUBE; Type 0: Not a Combination Product11/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/01/2017
Labeler - Private Label Select Ltd CO (005415463)
Registrant - Private Label Select Ltd CO (005415463)
Establishment
NameAddressID/FEIBusiness Operations
Private Label Select Ltd CO005415463manufacture(62932-156)

Revised: 3/2018
Document Id: 686c5f31-96af-e955-e053-2991aa0a10de
Set id: 686c5f31-96ae-e955-e053-2991aa0a10de
Version: 3
Effective Time: 20180327
 
Private Label Select Ltd CO