Label: GOODSENSE MEDICATED DANDRUFF ANTI-SEBORRHEIC DERMATITIS, ANTI-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 30, 2020

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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

    Ask 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 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

  • SPL UNCLASSIFIED SECTION

    Distributed by: Geiss, Destin & Dunn, Inc.
    Peachtree City, GA 30269

  • PRINCIPAL DISPLAY PANEL - 325 mL Bottle Label

    GOODSENSE®

    Medicated

    Selenium Sulfide 1%
    Dandruff
    Shampoo

    Maximum
    Medicated Control
    Healthier Hair
    Healthier Scalp

    Compare to active ingredient of
    Selsun Blue® Medicated
    Dandruff Shampoo
    100%
    SATISFACTION
    GUARANTEED

    11 FL. OZ. (325 mL)

    05-1788B

    PRINCIPAL DISPLAY PANEL - 325 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    GOODSENSE MEDICATED DANDRUFF   ANTI-SEBORRHEIC DERMATITIS, ANTI-DANDRUFF
    selenium sulfide shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-883
    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:50804-883-01325 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart358H03/01/2018
    Labeler - Geiss, Destin & Dunn, Inc. (076059836)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries INC255106239MANUFACTURE(50804-883)
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