Label: HEAD AND SHOULDERS HEADSTRONG DAILY DANDRUFF- pyrithione zinc shampoo

  • 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 5, 2020

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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, cocamide MEA, sodium xylenesulfonate, zinc carbonate, glycol distearate, sodium lauryl sulfate, cocamidopropyl betaine, sodium chloride, fragrance, dimethicone, guar hydroxypropyltrimonium chloride, sodium benzoate, stearyl alcohol, magnesium carbonate hydroxide, cetyl alcohol, polyquaternium-76, prunus amygdalus dulcis (sweet almond) oil, methylchloroisothiazolinone, methylisothiazolinone.

  • Questions (or comments)?

    1-800-723-9569

  • SPL UNCLASSIFIED SECTION

    Dist. by PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 950 mL Bottle Label

    head &
    shoulders ®
    pyrithione zinc dandruff shampoo

    #HEADSTRONG
    Daily Dandruff Shampoo

    with microzinc boosters for

    nourished scalp & hair

    32.1 FL OZ (950 mL)

    HS

  • INGREDIENTS AND APPEARANCE
    HEAD AND SHOULDERS HEADSTRONG DAILY DANDRUFF 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-323
    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
    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)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    ZINC CARBONATE (UNII: EQR32Y7H0M)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-323-40400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/31/2018
    2NDC:69423-323-95950 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/31/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H12/31/2018
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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