PYRITHIONE ZINC- pyrithione zinc shampoo 
Cosmetic Dermatology Research Institute, LLC.

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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71440-001-08

8oz

PYRITHIONE ZINC 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71440-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC2.41 g  in 237 mL
Inactive Ingredients
Ingredient NameStrength
PANTHENOL (UNII: WV9CM0O67Z)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
D&C VIOLET NO. 2 (UNII: 350KA7O6HK)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
LINALOOL, (+)- (UNII: F4VNO44C09)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
COCAMIDE (UNII: 3YXD33R71G)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71440-001-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product08/27/2021
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H03/07/2016
Labeler - Cosmetic Dermatology Research Institute, LLC. (833043586)
Registrant - Chemco Corporation. (032495954)
Establishment
NameAddressID/FEIBusiness Operations
Chemco Corporation032495954manufacture(71440-001)

Revised: 5/2022
Document Id: df71459e-2e31-8b2e-e053-2a95a90a83a8
Set id: 503599c1-dff7-0847-e054-00144ff88e88
Version: 5
Effective Time: 20220520
 
Cosmetic Dermatology Research Institute, LLC.