Label: TOPCO ASSOCIATES- 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 May 4, 2023

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  • ACTIVE INGREDIENT

    Selenium Sulfide 1%

  • PURPOSE

    anti dandruff

  • WARNINGS

    For external use only.

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

    ■ avoid contact with eyes. If contact occurs, rinse thoroughly with water.
    ■ for use on 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. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    ■ shake well, wet hair, massage onto scalp and rinse.
    ■ for best results, use at least twice a week or as directed by a doctor.

  • STORAGE AND HANDLING

    store at room temperature.

  • INACTIVE INGREDIENT

    Water (Aqua), Sodium Laureth Sulfate, TEA-Lauryl Sulfate, Cocamidopropyl Betaine, Acrylates Copolymer, Citric Acid,
    Fragrance (Parfum), Ammonium Chloride, Menthol, Sodium Hydroxide, Magnesium Aluminum Silicate, Hydroxypropyl Methylcellulose,
    Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Red 33 (CI 17200).

  • QUESTIONS

    1-888-423-0139

  • INDICATIONS & USAGE

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

  • PRINCIPAL DISPLAY PANEL

    11 oz

  • INGREDIENTS AND APPEARANCE
    TOPCO ASSOCIATES 
    selenium sulfide shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-171
    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
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    AMMONIUM CHLORIDE (UNII: 01Q9PC255D)  
    WATER (UNII: 059QF0KO0R)  
    TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
    MAGNESIUM ALUMINUM SILICATE TYPE IA (UNII: SUS08ZOA9S)  
    HYDROXYPROPYL METHACRYLATE (UNII: UKW89XAX2X)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    MENTHOL (UNII: L7T10EIP3A)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76162-171-11325 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/04/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03205/04/2023
    Labeler - Topco Associates (006935977)
    Registrant - Apollo Health and Beauty Care (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care201901209manufacture(76162-171)
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