Label: HEAD AND SHOULDERS SUPREME COLOR PROTECT- pyrithione zinc shampoo

  • NDC Code(s): 69423-346-35
  • 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 6, 2023

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  • 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, argania spinosa kernel oil, honey extract, sodium citrate, acrylates copolymer, fragrance, polyquaternium-10, 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

    COLOR

    PROTECT

    WITH ARGAN OIL

    & MANUKA HONEY

    FREE FROM

    SULFATES PHOSPHATES

    PARABENS

    PHTHALATES

    DYES

    11.8 FL OZ
    (350 mL)

    HS

  • INGREDIENTS AND APPEARANCE
    HEAD AND SHOULDERS SUPREME COLOR PROTECT 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-346
    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)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)  
    HONEY (UNII: Y9H1V576FH)  
    DIMETHICONOL GUM (UNII: 4MJ9GU3T1P)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-346-35350 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/02/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03205/02/2019
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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