Label: MEIJER MEDICATED SELENIUM SULFIDE ANTI-DANDRUFF- selenium sulfide shampoo

  • NDC Code(s): 41250-545-01
  • Packager: Meijer Distribution, INC
  • 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 14, 2021

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Selenium Sulfide 1%

  • Purpose

    Anti-dandruff

  • Use

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

  • Warnings

    For external use only

    As a doctor before use if you have

    seborrheic dermatitis in areas other than the scalp.

    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 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, cocamidopropyl betaine, cocamide MEA, magnesium aluminum silicate, hydroxypropyl methylcellulose, fragrance, menthol, DMDM Hydantoin, citric acid, sodium chloride, blue 1, red 33

  • SPL UNCLASSIFIED SECTION

    DIST BY MEIJER
    DISTRIBUTION, INC.
    2929 WALKER AVE NW
    GRAND RAPIDS, MI 49544

  • PRINCIPAL DISPLAY PANEL - 325 mL Bottle Label

    meijer

    MEDICATED

    selenium
    sulfide
    DANDRUFF
    SHAMPOO

    formulated to fight
    seborrheic dermatitis
    and dandruff symptoms
    with menthol
    1% selenium sulfide

    Original
    Formula

    Compare to
    Selsun Blue®
    active ingredient*

    11 FL OZ (325 mL)

    05-1522B

    PRINCIPAL DISPLAY PANEL - 325 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    MEIJER MEDICATED SELENIUM SULFIDE   ANTI-DANDRUFF
    selenium sulfide shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-545
    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)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Coco Monoethanolamide (UNII: C80684146D)  
    Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)  
    Hypromellose, Unspecified (UNII: 3NXW29V3WO)  
    Menthol, Unspecified Form (UNII: L7T10EIP3A)  
    DMDM Hydantoin (UNII: BYR0546TOW)  
    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:41250-545-01325 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/11/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart358H05/11/2010
    Labeler - Meijer Distribution, INC (006959555)
    Registrant - SIGAN INDUSTRIES INC. (255106239)
    Establishment
    NameAddressID/FEIBusiness Operations
    SIGAN INDUSTRIES INC.255106239MANUFACTURE(41250-545)