Label: HEAD AND SHOULDERS 2IN1 CLINICAL STRENGTH DANDRUFF DEFENSE ADVANCED OIL CONTROL- selenium sulfide lotion/shampoo

  • NDC Code(s): 69423-524-40
  • 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 June 13, 2023

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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.

    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.
    • caution: if used on bleached, tinted, grey, or permed hair, rinse for 5 minutes.
  • Inactive ingredients

    Water, ammonium laureth sulfate, ammonium lauryl sulfate, glycol distearate, cocamide MEA, ammonium xylenesulfonate, fragrance, sodium citrate, dimethicone, cetyl alcohol, citric acid, sodium chloride, sodium benzoate, disodium EDTA, stearyl alcohol, hydroxypropylmethylcellulose,methylchloroisothiazolinone, methylisothiazolinone, red 4.

  • Questions (or comments)?

    1-800-723-9569

  • SPL UNCLASSIFIED SECTION

    Dist. by PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - BOTTLE LABEL

    head &

    shoulders ®

    selenium sulfide dandruff &

    seborrheic dermatitis shampoo

    2in1

    Clinical Strength

    Dandruff Defense

    Extra Strength Formula

    with Refreshing Citrus

    13.5 FL OZ (400 mL)

    HS

  • INGREDIENTS AND APPEARANCE
    HEAD AND SHOULDERS 2IN1 CLINICAL STRENGTH DANDRUFF DEFENSE ADVANCED OIL CONTROL 
    selenium sulfide lotion/shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-524
    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
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    AMMONIUM XYLENESULFONATE (UNII: 4FZY6L6XCM)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-524-40400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03211/17/2020
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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