Label: HEAD AND SHOULDERS BARE MINIMAL INGREDIENTS SOOTHING HYDRATION- pyrithione zinc shampoo

  • NDC Code(s): 69423-722-40
  • 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 July 11, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Pyrithione zinc 1%

  • Purpose

    Anti-dandruff

  • Uses

    fights recurrence of the symptoms 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

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

    Water, lauramidopropyl betaine, sodium cocoyl isethionate, fragrance, polyquaternium-10, acrylates copolymer, sodium benzoate, citric acid

  • Questions (or comments)?

    1-800-723-9569

  • SPL UNCLASSIFIED SECTION

    Dist. by PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 400 mL Bottle Label

    head &
    shoulders ®
    PYRITHIONE ZINC DANDRUFF SHAMPOO

    BARE MINIMAL INGREDIENTS SHAMPOO

    SOOTHING HYDRATION

    0% SULFATES

    DYES

    SILICONES

    13.5 FL OZ
    (400 mL)

    HS

  • INGREDIENTS AND APPEARANCE
    HEAD AND SHOULDERS BARE MINIMAL INGREDIENTS SOOTHING HYDRATION 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-722
    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
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    WATER (UNII: 059QF0KO0R)  
    LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-722-40400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03204/01/2023
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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