Label: HEAD AND SHOULDERS SUPREME HYDRATING SCALP SERUM- pyrithione zinc liquid

  • NDC Code(s): 69423-426-40
  • Packager: The Procter & Gamble Manufacturing Company
  • 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 January 5, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Pyrithione zinc 0.1%

  • Purpose

    Anti-dandruff

  • Use

    for the relief of dandruff.

  • Warnings

    For external use only.

    When using this product

    • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

    Stop use and ask a doctor if

    • condition worsens or does not improve after regular use of this product as directed.

    Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply to affected areas one to four times daily or as directed by a doctor.
    • twist the cap open. Place tip directly onto scalp (damp or dry).
    • gently squeeze the bottle while moving tip from front to back of your scalp. Repeat to cover your entire scalp.
    • massage for even distribution. Do not rinse.

  • Inactive ingredients

  • Questions (or comments)?

    1-800-723-9569

  • SPL UNCLASSIFIED SECTION

    Dist. by PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 40 mL bottle label

    head &
    shoulders ®

    pyrithione zinc dandruff treatment

    SUPREME

    HYDRATING

    SCALP SERUM

    INTENSELY HYDRATES TO

    REPLENISH THE SCALP IN

    BETWEEN WASHES

    WITH VITAMIN E

    & ARGAN OIL

    1.3 FL OZ (40 mL)

    HS

  • INGREDIENTS AND APPEARANCE
    HEAD AND SHOULDERS SUPREME HYDRATING SCALP SERUM 
    pyrithione zinc liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-426
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    WATER (UNII: 059QF0KO0R)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CAFFEINE (UNII: 3G6A5W338E)  
    BIS-PEG/PPG-16/16 PEG/PPG-16/16 DIMETHICONE (UNII: 55A74AJ3KB)  
    EDETOL (UNII: Q4R969U9FR)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-426-4040 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/16/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03212/16/2019
    Labeler - The Procter & Gamble Manufacturing Company (004238200)