Label: MEDICATED 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 June 1, 2012

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Active ingredient
    Selenium sulfide 1%

    Purpose
    Anti-Dandruff
  • INDICATIONS & USAGE

    Use for relief of itching and flaking associated with dandruff and seborrheic dermatitis and to help prevent reoccurrence
  • WARNINGS

    Warnings
    For external use only

    Ask a doctor before use if you have seborrheic dermatitis in areas other than the scalp

    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, bet medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION

    Directions •Shake well •wet hair, massage onto scalp, rinse thoroughly
    •for best results use at least twice a week or as directed b a doctor
  • OTHER SAFETY INFORMATION

    Other information for color-treated or permed hair, rinse extra thoroughly
  • INACTIVE INGREDIENT

    Inactive ingredients water, ammonium laury sulfate, TEA-lauryl sulfate, ammonium laureth sulfate,  cocamidopropyl betaine, magnesium aluminum silicate, fragrance,
    menthol, cocamide DEA, DMDM hydantoin citric acid, hydroxypropyl methylcellulose, xanthan gum, cellulose gum, FD+C blue no. 1, D+C red no 33, sodium citrate, sodium chloride.
  • ADVERSE REACTIONS

    PACKAGED FOR DOLGENCORP, LLC
    100 MISSION RIDGE, GOODLETTSVILLE, TN 37072 USA
    visit us at Rexall.com or call 1-866-4-REXALL
  • PRINCIPAL DISPLAY PANEL

    Since 1903
    Rexall
    MAXIMUM
    DANDRUFF
    CONTROL
    SHAMPOO
    Selenium Sulfide
    Dandruff Shampoo
    •For a healthier scalp and hair
    •Helps prevent flakes
    11 FL OZ (325 mL)
    image of principal display package
  • INGREDIENTS AND APPEARANCE
    MEDICATED DANDRUFF 
    selenium sulfide shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-246
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SELENIUM SULFIDE (UNII: Z69D9E381Q) (SELENIUM SULFIDE - UNII:Z69D9E381Q) SELENIUM SULFIDE1 kg  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    TROLAMINE LAURYL SULFATE (UNII: E8458C1KAA)  
    AMMONIUM LAURETH-3 SULFATE (UNII: 896SJ235FN)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    MENTHOL (UNII: L7T10EIP3A)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-246-39.325 L in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H11/03/2011
    Labeler - Dolgencorp.LLC (068331990)
    Registrant - Vi-Jon (088520668)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon088520668manufacture
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!