Label: PYRITHIONE ZINC shampoo

  • NDC Code(s): 50157-125-10, 50157-125-35
  • Packager: BRANDS INTERNATIONAL
  • 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 August 4, 2023

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

View All Sections
  • DOSAGE & ADMINISTRATION

    For maximum dandruff control, use every time you shampoo.
    Wet hair, massage unto scalp, rinse, and repeat if desired.

    For best results use at least twice a week or as directed by a doctor.

  • WARNINGS

    For external use only.

  • INACTIVE INGREDIENT

    Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Glycol Distearate, Aloe vera Leaf Extract, Parfum, Vitamin E, Methylchloroisothiazolinone,Methylisothiazolinone, FD&C Blue#1 ,FD&C Red#33.

  • INDICATIONS & USAGE

    Helps prevent recurrence of flaking and itching associated with dandruff.

  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of children’s reach.

  • PURPOSE

    Anti-dandruff

  • ACTIVE INGREDIENT

    Pyrithione Zinc 0.3%

  • STOP USE

    Condition worsens or does not improve after regular use of this product as directed

  • WHEN USING

    Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    PYRITHIONE ZINC 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-125
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    BASIC BLUE 1 (UNII: 92N74OA24D)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50157-125-10295 mL in 1 BOTTLE; Type 0: Not a Combination Product08/16/2022
    2NDC:50157-125-35355 mL in 1 BOTTLE; Type 0: Not a Combination Product08/16/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03208/16/2022
    Labeler - BRANDS INTERNATIONAL (243748238)
    Establishment
    NameAddressID/FEIBusiness Operations
    BRANDS INTERNATIONAL243748238manufacture(50157-125)
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!