Label: HEAD AND SHOULDERS CLINICAL STRENGTH- selenium sulfide lotion/shampoo

  • NDC Code(s): 37000-330-01, 37000-330-40, 37000-330-70
  • 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 January 20, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Selenium sulfide 1%

  • Purpose

    Anti-dandruff, Anti-seborrheic dermatitis

  • Uses

    helps prevent recurrence of flaking, itching, irritation, scaling and redness associated with dandruff and seborrheic dermatitis.

  • Warnings

    For external use only.

    Ask a doctor before use if you have a condition that covers a large area of the body.

    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

    • caution: if used on bleached, tinted, grey, or permed hair, rinse for 5 minutes.
    • 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, ammonium laureth sulfate, ammonium lauryl sulfate, glycol distearate, cocamide MEA, ammonium xylenesulfonate, sodium citrate, fragrance, dimethicone, cetyl alcohol, sodium chloride, citric acid, sodium benzoate, stearyl alcohol, sisodiumEDTA, sodium laureth sulfate, hydroxypropyl methylcellulose, camphor, eucalyptol, methylchloroisothiazolinone, methylisothiazolinone, red 4.

  • Questions (or comments)?

    1-800-723-9569

  • SPL UNCLASSIFIED SECTION

    Dist. by PROCTER & GAMBLE,
    CINCINNATI, OH 45202

    www.headandshoulders.com

  • PRINCIPAL DISPLAY PANEL - 400 mL Bottle Label

    head &

    shoulders ®

    selenium sulfide dandruff
    and seborrheic dermatitis shampoo

    clinical strength

    clinically proven relief for severe dandruff

    13.5 FL OZ (400 mL)

    HS

  • INGREDIENTS AND APPEARANCE
    HEAD AND SHOULDERS  CLINICAL STRENGTH
    selenium sulfide lotion/shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-330
    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)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    AMMONIUM LAURETH-3 SULFATE (UNII: 896SJ235FN)  
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    AMMONIUM XYLENESULFONATE (UNII: 4FZY6L6XCM)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    Product Characteristics
    ColororangeScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-330-40400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/201011/19/2022
    2NDC:37000-330-70700 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/13/201710/22/2022
    3NDC:37000-330-012 in 1 CELLO PACK11/09/201810/22/2022
    3400 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 finalpart358H07/01/201011/19/2022
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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