Label: HEAD AND SHOULDERS DRY SCALP CARE- pyrithione zinc lotion/shampoo

  • NDC Code(s): 37000-092-01, 37000-092-10, 37000-092-25, 37000-092-37, view more
    37000-092-40, 37000-092-61, 37000-092-70, 37000-092-71, 37000-092-83, 37000-092-95
  • 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 February 28, 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 laureth sulfate, sodium lauryl sulfate, cocamidopropyl betaine, sodium xylenesulfonate, zinc carbonate, glycol distearate, fragrance, sodium chloride, dimethiconol, sodium benzoate, guar hydroxypropyltrimonium chloride, dimethicone,TEA-dodecylbenzenesulfonate, magnesium carbonate hydroxide, trideceth-10, prunus amygdalus dulcis (sweet almond) oil, benzyl alcohol, methylchloroisothiazolinone, methylisothiazolinone

  • Questions (or comments)?

    1-800-723-9569

  • SPL UNCLASSIFIED SECTION

    Dist. by PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 835mL Bottle Label

    head &
    shoulders ®
    pyrithione zinc dandruff shampoo

    DRY SCALP CARE
    Daily Shampoo


    CLINICALLY PROVEN TO HELP
    RESTORE SCALP'S NATURAL MOISTURE
    INFUSED WITH ALMOND OIL

    FLAKE FREE.*

    UP TO 100%

    GUARANTEED^

    28.2 FL OZ (835 mL)

    HS

  • INGREDIENTS AND APPEARANCE
    HEAD AND SHOULDERS  DRY SCALP CARE
    pyrithione zinc lotion/shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-092
    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
    DIMETHICONOL GUM (UNII: 4MJ9GU3T1P)  
    TRIDECETH-10 (UNII: G624N6MSBA)  
    TRIETHANOLAMINE DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ZINC CARBONATE (UNII: EQR32Y7H0M)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-092-70700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/201310/05/2018
    2NDC:37000-092-101000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/201310/05/2018
    3NDC:37000-092-40400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/22/201401/01/2025
    4NDC:37000-092-25250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/30/201504/01/2023
    5NDC:37000-092-95950 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/01/201601/01/2025
    6NDC:37000-092-71700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/23/201801/01/2025
    7NDC:37000-092-012 in 1 CELLO PACK07/15/2020
    7950 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    8NDC:37000-092-37370 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2022
    9NDC:37000-092-61613 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2022
    10NDC:37000-092-83835 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03209/01/2013
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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