Label: HEAD AND SHOULDERS SUPREME SCALP MOISTURIZER WITH HEMP SEED- pyrithione zinc lotion

  • 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 27, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Pyrithione zinc 0.1%

  • 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

    • apply to affected areas one to four times daily or as directed by a doctor.

  • Inactive ingredients

    Water, cannabis sativa seed oil, cetyl alcohol, stearamidopropyl dimethylamine, stearyl alcohol, hydroxyethylcellulose, quaternium-18, phenoxyethanol, fragrance, benzyl alcohol, PEG-2M, cetearyl alcohol, methylparaben, dimethicone, glyceryl stearate, oleyl alcohol, propylparaben, citric acid, polysorbate 60.

  • Questions (or comments)?

    1-800-723-9569

  • SPL UNCLASSIFIED SECTION

    Dist. by PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 50 mL bottle label

    Head & Shoulders

    PYRITHIONE ZINC DANDRUFF TREATMENT

    SUPREME SCALP MOISTURIZER

    HEMP OIL ESSENTIAL OIL

    NOURISHES DRY SCALP,

    HELPS STRENGTHEN HAIR

    1.69 FL OZ (50 mL)

    HS

  • INGREDIENTS AND APPEARANCE
    HEAD AND SHOULDERS SUPREME SCALP MOISTURIZER WITH HEMP SEED 
    pyrithione zinc lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-569
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYETHYLENE OXIDE 100000 (UNII: V46Y6OJ5QB)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    QUATERNIUM-18 (UNII: O7757NO1VL)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    WATER (UNII: 059QF0KO0R)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-569-5050 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H02/01/2021
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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