Label: PYRITHIONE ZINC shampoo

  • NDC Code(s): 71440-001-08
  • Packager: Cosmetic Dermatology Research Institute, LLC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 May 20, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

  • PURPOSE

  • WARNINGS

  • WHEN USING

  • KEEP OUT OF REACH OF CHILDREN

  • STOP USE

  • INACTIVE INGREDIENT

  • DOSAGE & ADMINISTRATION

  • INDICATIONS & USAGE

  • PRINCIPAL DISPLAY PANEL

    8oz

  • INGREDIENTS AND APPEARANCE
    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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!