Label: HEAD AND SHOULDERS SUPREME SOOTHE AND STRENGTHEN- pyrithione zinc shampoo

  • NDC Code(s): 69423-345-35, 69423-345-83
  • 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 April 4, 2023

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Pyrithione zinc 1%

  • Purpose

    Anti-dandruff

  • Uses

    helps prevent recurrence of flaking and itching associated with 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

    • for best results use at least twice a week or as directed by a doctor.
    • for maximum dandruff control, use every time you shampoo.
    • shake before use.
    • wet hair, massage onto scalp, rinse, repeat if desired.
  • Inactive Ingredients

    Water, lauramidopropyl betaine, sodium cocoyl isethionate, sodium lauroyl sarcosinate, sodium chloride, rosa gallica flower extract, argania spinosa kernel oil, sodium citrate, acrylates copolymer, polyquaternium-10, fragrance, dimethiconol, citric acid, sodium benzoate, sodium salicylate.

  • Questions (or comments)?

    1-800-723-9569

  • SPL UNCLASSIFIED SECTION

    Dist. by PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 350 mL Bottle Label

    head &
    shoulders ®
    PYRITHIONE ZINC DANDRUFF

    SCALP & HAIR SHAMPOO

    SUPREME

    SOOTHE &

    STRENGTHEN

    WITH ARGAN OIL

    & ROSE ESSENCE

    FREE FROM

    SULFATES

    DYES

    PARABENS

    PHOSPHATES

    PHTHALATES

    11.8 FL OZ
    (350 mL)

    HS

  • INGREDIENTS AND APPEARANCE
    HEAD AND SHOULDERS SUPREME SOOTHE AND STRENGTHEN 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-345
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM SALICYLATE (UNII: WIQ1H85SYP)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)  
    ROSA GALLICA FLOWER (UNII: X8W61WUV70)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    DIMETHICONOL GUM (UNII: 4MJ9GU3T1P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-345-35350 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/02/2019
    2NDC:69423-345-83835 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/15/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03205/02/2019
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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!