Label: HEAD AND SHOULDERS SUPREME DETOXIFYING PRE-WASH MASK- pyrithione zinc cream

  • NDC Code(s): 69423-407-50
  • 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, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, zinc carbonate, sodium chloride, sodium xylenesulfonate, fragrance, argania spinosa kernel oil, tocopheryl acetate, cocamidopropyl betaine, dimethicone, menthol, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, mentha piperita (peppermint) oil, mentha arvensis leaf oil, eucalyptus globulus leaf extract, methylchloroisothiazolinone, methylisothiazolinone.

  • Questions (or comments)?

    1-800-723-9569

  • SPL UNCLASSIFIED SECTION

    Dist. by PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 50 mL pouch Label

    head &
    shoulders ®
    pyrithione zinc dandruff treatment

    SUPREME

    DETOXIFYING

    SCALP PRE-WASH MASK

    DEEPLY CLEANSES, REMOVES

    BUILD UP & DETOXIFIES THE SCALP

    WITH VITRAMIN E

    & ARGAN OIL

    1.6 FL OZ (50 mL)

    HS

  • INGREDIENTS AND APPEARANCE
    HEAD AND SHOULDERS SUPREME DETOXIFYING PRE-WASH MASK 
    pyrithione zinc cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-407
    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 LAURYL SULFATE (UNII: 368GB5141J)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
    ZINC CARBONATE (UNII: EQR32Y7H0M)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-407-5050 mL in 1 POUCH; Type 0: Not a Combination Product11/21/201909/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03211/21/201909/01/2024
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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