Label: HEAD AND SHOULDERS DEEP SCALP CLEANSE 2IN1- pyrithione zinc lotion/shampoo

  • NDC Code(s): 69423-698-37
  • 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 30, 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, sodium chloride, fragrance, cocamidopropyl betaine, sodium xylenesulfonate, dimethicone, sodiumbenzoate, guar hydroxypropyltrimonium chloride, stearyl stearate,magnesium carbonate hydroxide, sodium laureth sulfate, euphorbia cerifera (candelilla) wax, jojoba esters, ferric ammonium ferrocyanide, red 33, blue 1

  • Questions (or comments)?

    1-800-723-9569

  • SPL UNCLASSIFIED SECTION

    MADE IN U.S.A. of U.S. and/or Imported Ingredients

    Dist. by PROCTER & GAMBLE,

    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 370 mL Bottle Label

    head &
    shoulders ®

    PYRITHIONE ZINC DANDRUFF

    SHAMPOO + CONDITIONER

    DEEP SCALP

    CLEANSE

    2in1

    Cleans deep into scalp pores

    without stripping natural oils

    WITH NATURALLY-DERIVED

    EXFOLIANTS

    12.5 FL OZ (370 mL)

    HS

  • INGREDIENTS AND APPEARANCE
    HEAD AND SHOULDERS DEEP SCALP CLEANSE 2IN1 
    pyrithione zinc lotion/shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-698
    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
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ZINC CARBONATE (UNII: EQR32Y7H0M)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)  
    STEARYL STEARATE (UNII: 5WX2EGD0DK)  
    FERRIC AMMONIUM FERROCYANIDE (UNII: 9R0NVI936I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-698-37370 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/15/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03212/15/2022
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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