Label: LEADER MEDICATED DANDRUFF ANTI-SEBORRHEIC DERMATITIS, ANTI-DANDRUFF- selenium sulfide shampoo

  • NDC Code(s): 70000-0531-1
  • Packager: Cardinal Health, 110 dba LEADER
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 13, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Selenium Sulfide 1%

  • Purpose

    Anti-seborrheic dermatitis, anti-dandruff

  • Uses

    for the relief of flaking and itching associated with dandruff and seborrheic dermatitis and to help prevent their recurrence.

  • Warnings

    For external use only

    As a doctor before use if

    ♦
    condition covers a large area of the body.

    When using this product

    ♦
    avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.
    ♦
    for color-treated or permed hair, rinse thoroughly.

    Stop use and ask a doctor if

    ♦
    condition worsens or does not improve after regular use of this product as directed.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    ♦
    shake well
    ♦
    shampoo, then rinse thoroughly
    ♦
    for best results, use at least twice a week or as directed by a doctor.
  • Other information

    store at room temperature

  • Inactive ingredients

    water, ammonium laureth sulfate, ammonium lauryl sulfate, cocamide MEA, cocamidopropyl betaine, magnesium aluminum silicate, hydroxypropyl methylcellulose, fragrance, menthol, chlorphenesin, phenoxyethanol, citric acid, sodium chloride, blue 1, red 33

  • Questions or comments?

    1-866-567-8600

  • SPL UNCLASSIFIED SECTION

    DIST BY CAH, DUBLIN, OH 43017

  • PRINCIPAL DISPLAY PANEL - 207 mL Bottle Label

    LEADER™

    NDC 70000-0531-1

    Medicated
    Dandruff
    Shampoo

    Selenium Sulfide, 1%
    Anti-Seborrheic Dermatitis
    Anti-Dandruff

    With Menthol

    For the Relief
    of Seborrheic
    Dermatitis
    and Dandruff
    Symptoms

    COMPARE TO
    SELSUN BLUE®
    active ingredient*

    100% Money
    Back Guarantee

    7 FL OZ (207 mL)

    05-3793

    PRINCIPAL DISPLAY PANEL - 207 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    LEADER MEDICATED DANDRUFF   ANTI-SEBORRHEIC DERMATITIS, ANTI-DANDRUFF
    selenium sulfide shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0531
    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-5 SULFATE (UNII: 43ZIH89I48)  
    Ammonium Lauryl Sulfate (UNII: Q7AO2R1M0B)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    Chlorphenesin (UNII: I670DAL4SZ)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Product Characteristics
    ColorGREENScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0531-1207 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/05/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM03211/05/2019
    Labeler - Cardinal Health, 110 dba LEADER (063997360)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries INC255106239MANUFACTURE(70000-0531)
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