Label: HEAD AND SHOULDERS SMOOTH AND SILKY- pyrithione zinc lotion/shampoo

  • NDC Code(s): 37000-094-10, 37000-094-37, 37000-094-38, 37000-094-40, view more
    37000-094-50, 37000-094-61, 37000-094-65, 37000-094-70, 37000-094-90
  • 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 24, 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, sodiumchloride, cocamidopropyl betaine, fragrance, sodium xylenesulfonate, dimethicone, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, sodium laureth sulfate,methylchloroisothiazolinone, methylisothiazolinone

  • Questions (or comments)?

    1-800-723-9569

  • SPL UNCLASSIFIED SECTION

    Dist. by PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 370 mL Bottle Label

    head &

    shoulders ®
    pyrithione zinc dandruff shampoo

    SMOOTH

    & SILKY

    DAILY SHAMPOO


    24 hour frizz control from root to tip

    UP TO 100%

    COLOR SAFE +

    DANDRUFF PROTECTION*

    12.5 FL OZ
    370 mL

    HS

  • INGREDIENTS AND APPEARANCE
    HEAD AND SHOULDERS  SMOOTH AND SILKY
    pyrithione zinc lotion/shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-094
    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
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    ZINC CARBONATE (UNII: EQR32Y7H0M)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-094-1010 mL in 1 POUCH; Type 0: Not a Combination Product09/01/2013
    2NDC:37000-094-70700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/201312/21/2019
    3NDC:37000-094-40400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/01/201312/21/2019
    4NDC:37000-094-9090 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/11/201702/28/2023
    5NDC:37000-094-38380 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/11/201701/01/2025
    6NDC:37000-094-65650 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/11/201701/01/2025
    7NDC:37000-094-5050 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/15/202008/30/2021
    8NDC:37000-094-37370 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/15/2022
    9NDC:37000-094-61613 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/15/2022
    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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