Label: HEAD AND SHOULDERS CLINICAL DRY SCALP RESCUE KIT- pyrithione zinc kit

  • NDC Code(s): 69423-523-40, 69423-568-27, 69423-673-01
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 6, 2024

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  • SPL UNCLASSIFIED SECTION

    head & shoulders
    CLINICAL STRENGTH SHAMPOO

    DANDRUFF DEFENSE

    DRY SCALP RESCUE

    Drug Facts

  • Active ingredient

    Selenium Sulfide 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

    sodium lauryl sulfate, glycol distearate, sodiumchloride, cocamidopropyl betaine, sodiumcitrate, sodiumxylenesulfonate, fragrance, dimethicone, citric acid, sodium benzoate, tetrasodiumEDTA, hydroxypropylmethylcellulose, honey extract, red 4.

  • Questions (or comments)?

    1-800-723-9569

  • SPL UNCLASSIFIED SECTION

    head & shoulders
    CLINICAL STRENGTH CONDITIONER

    DANDRUFF DEFENSE

    DRY SCALP RESCUE

    Drug Facts

  • Active ingredient

    Pyrithione zinc 0.5%

  • 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.
    • apply to wet hair after shampooing by gently massaging into hair and scalp, rinse well.
  • Inactive ingredients

    Water, stearyl alcohol, cetyl alcohol, stearamidopropyl dimethylamine, glutamic acid, dimethicone, fragrance, phenoxyethanol, benzyl alcohol,sodium chloride, citric acid, honey extract, methylchloroisothiazolinone, methylisothiazolinone

  • Questions (or comments)?

    1-800-723-9569

  • SPL UNCLASSIFIED SECTION

    Dist. by PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - Kit

    head & shoulders ®

    Shampoo & Conditioner

    head & shoulders ®

    selenium sulfide dandruff & soborrheic dermatitis shampoo

    CLINICAL STRENGTH

    DANDRUFF DEFENSE

    DRY SCALP

    RESCUE

    head & shoulders ®

    pyrithione zinc dandruff conditioner

    CLINICAL STRENGTH

    DANDRUFF DEFENSE

    DRY SCALP

    RESCUE

    1 SELENIUM SULFIDE DANDRUFF & SEBORRHEIC DERMATITIS

    SHAMPOO 13.5 FL OZ (400 mL)

    1 PYRITHIONE ZINC DANDRUFF

    CONDITIONER 9.1 FL OZ (270 mL)

    HS

  • INGREDIENTS AND APPEARANCE
    HEAD AND SHOULDERS CLINICAL DRY SCALP RESCUE KIT 
    pyrithione zinc kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-673
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-673-011 in 1 PACKAGE, COMBINATION03/15/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 400 mL
    Part 21 TUBE 270 mL
    Part 1 of 2
    HEAD AND SHOULDERS CLINICAL STRENGTH DANDRUFF DEFENSE DRY SCALP RESCUE 
    selenium sulfide lotion/shampoo
    Product Information
    Item Code (Source)NDC:69423-523
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q) SELENIUM SULFIDE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    WATER (UNII: 059QF0KO0R)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM XYLENESULFONATE (UNII: G4LZF950UR)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HONEY (UNII: Y9H1V576FH)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-523-40400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03203/15/2023
    Part 2 of 2
    HEAD AND SHOULDERS CLINICAL DANDRUFF DEFENSE DRY SCALP RESCUE 
    pyrithione zinc lotion
    Product Information
    Item Code (Source)NDC:69423-568
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.75 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)  
    GLUTAMIC ACID (UNII: 3KX376GY7L)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    HONEY (UNII: Y9H1V576FH)  
    COCONUT (UNII: 3RT3536DHY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-568-27270 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03201/11/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03203/15/2023
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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