Label: DANDRUFF- selenium sulfide 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 January 12, 2023

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  • Active ingredient

    Selenium sulfide 1%

  • Purpose

    Anti-dandruff, Anti-seborrheic dermatitis

  • Use

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

  • Warnings

    For external use only

  • Ask a doctor before use if

    condition covers a large area of the body

  • When using this product

    • do not get into 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 as directed
  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • shake well
    • for maximum dandruff control, use every time you shampoo
    • wet hair,massage onto scalp, rinse, repeat if desired
    • for best results use at least twice a week or as directed by a doctor
    • if used on bleached, gray, tinted or permed hair, rinse for at least 5 minutes
  • Inactive ingredients

    water, ammonium laureth sulfate, ammonium lauryl sulfate, glycol distearate, cocamide MEA, ammonium xylenesulfonate, sodium citrate, fragrance, amodimethicone, cetyl alcohol, sodium chloride, citric acid, sodium benzoate, stearyl alcohol, disodium EDTA, hydrogen peroxide, hydroxypropyl methylcellulose, methylchlorisothiazolinone, methylisothiazolinone, red 4

  • SPL UNCLASSIFIED SECTION

    CVS/pharmacy Maximum Strength Dandruff shampoo helps reduce itching, flaking, scaling, irritation and redness

    due to severe dandruff and seborrheic dermatitis. This advanced formula cleanses and help relieve itch, leaving hair soft and manageable.

    Helps control and protect against dandruff from the first wash
    Gentle and pH balanced for everyday use, even for permed or color-treated hair

    *This product is not manufactured or distributed by Procter + Gamble, owner of the registered trademark Head + Shoulders

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    2013CVS/pharmacy

    www.cvs.com 1-800-shop-CVS

    Made in the U.S.A. of U.S. and imported parts

  • principal display panel

    CVS pharmacy dandruff shampoo

    Maximum strength Selenium sulfide dandruff + seborrheic dermatitis shampoo

    Helps relieve stubbon dandruff

    Dermatologist tested

    Compare to the active ingredient in Head + Shoulders Clinical Strength Dandruff Shampoo*

    14.2 FL OZ (420 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    DANDRUFF 
    selenium sulfide shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-589
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q) SELENIUM SULFIDE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM LAURETH-3 SULFATE (UNII: 896SJ235FN)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    AMMONIUM XYLENESULFONATE (UNII: 4FZY6L6XCM)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    AMODIMETHICONE (800 CST) (UNII: 363Z2T48P7)  
    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)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-589-15420 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/09/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H12/09/2012
    Labeler - CVS (062312574)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(59779-589)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(59779-589)
    Establishment
    NameAddressID/FEIBusiness Operations
    RWM TECHNOLOGIES LLC626626969manufacture(59779-589)
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