Label: HEAD AND SHOULDERS SCALP RESTORE- pyrithione zinc shampoo

  • NDC Code(s): 69423-646-11
  • 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, glycol distearate, zinc carbonate, sodium chloride, cocamidopropyl betaine, sodium xylenesulfonate, fragrance, dimethicone, sodium benzoate, menthol, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, sodium laureth sulfate, mentha piperita (peppermint) oil, mentha arvensis leaf oil, tocopheryl acetate, melaleuca alternifolia (tea tree) leaf oil, methylchloroisothiazolinone, methylisothiazolinone

  • Questions (or comments)?

    1-800-723-9569

  • SPL UNCLASSIFIED SECTION

    MADE IN U.S.A. of U.S. and/or Imported Ingredients

    Dist. by PROCTER & GAMBLE,

    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 1150 mL Bottle Label

    head &
    shoulders ®

    pyrithione zinc dandruff shampoo

    scalp restore

    SHAMPOO

    WITH TEA TREE OIL &

    ANTIOXIDANTS

    38.8 FL OZ (1.15 L)

    HS

  • INGREDIENTS AND APPEARANCE
    HEAD AND SHOULDERS SCALP RESTORE 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-646
    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
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    ZINC CARBONATE (UNII: EQR32Y7H0M)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    MENTHOL (UNII: L7T10EIP3A)  
    MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-646-111150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03206/01/2022
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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