Label: HEAD AND SHOULDERS MEN ADVANCED SERIES SAGE AND MINT 2IN1- pyrithione zinc shampoo

  • NDC Code(s): 69423-413-38
  • 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 March 31, 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, sodium xylenesulfonate, dimethicone, cocamidopropyl betaine, fragrance, sodiumbenzoate, guar hydroxypropyltrimoniumchloride, magnesium carbonate hydroxide, menthol, mentha piperita (peppermint) oil, mentha arvensis leaf oil, methylchloroisothiazolinone, methylisothiazolinone, blue 1, red 33

  • Questions (or comments)?

    1-800-723-9569

  • SPL UNCLASSIFIED SECTION

    Dist. by PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 380 mL Bottle Label

    head &
    shoulders ®
    PYRITHIONE ZINC DANDRUFF

    SHAMPOO + CONDITIONER

    2IN1

    MEN

    ADVANCED SERIES TM

    SAGE & MINT

    12.8 FL OZ (380 mL)

    HS

  • INGREDIENTS AND APPEARANCE
    HEAD AND SHOULDERS MEN ADVANCED SERIES SAGE AND MINT 2IN1 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-413
    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
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    WATER (UNII: 059QF0KO0R)  
    ZINC CARBONATE (UNII: EQR32Y7H0M)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
    MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-413-38380 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/21/201910/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03211/21/201910/01/2024
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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