Label: HEAD AND SHOULDERS SCALP X- pyrithione zinc shampoo

  • NDC Code(s): 69423-643-15
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 15, 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, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, sodium chloride, zinc carbonate, dimethicone, sodium xylenesulfonate, cocamidopropyl betaine, fragrance, sodium benzoate, menthol, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, mentha piperita (peppermint) oil, mentha arvensis leaf oil, tocopheryl acetate, methylchloroisothiazolinone, methylisothiazolinone

  • Questions (or comments)?

    1-800-723-9569

  • SPL UNCLASSIFIED SECTION

    Dist. by PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • Principal display panel - 150 mL Bottle Label

    head &

    shoulders

    PYRITHIONE ZINC

    DANDRUFF SHAMPOO

    SCALP X

    SHAMPOO

    REDUCES HAIR LOSS

    DUE TO BREAKAGE

    with Vitamin E

    5 FL OZ (150 mL)

    HS

  • INGREDIENTS AND APPEARANCE
    HEAD AND SHOULDERS SCALP X 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-643
    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
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
    ZINC CARBONATE (UNII: EQR32Y7H0M)  
    MENTHOL (UNII: L7T10EIP3A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-643-15150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/01/202209/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03209/01/202209/01/2024
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Procter & Gamble Manufacturing Company081329183manufacture(69423-643) , pack(69423-643)
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