Label: CAREONE MEDICATED DANDRUFF- selenium sulfide shampoo

  • NDC Code(s): 72476-025-03
  • Packager: Retail Business Services, LLC
  • 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 September 2, 2021

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

  • Active Ingredient

    Selenium Sulfide 1%

  • Purpose

    Anti-dandruff, Anti-seborrheic dermatitis

  • Uses

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

  • Warnings

    For external use only.

    Ask a doctor before use

    you have seborrheic dermatitis in areas other than the scalp.

    When using this Product

    • 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.

  • Directions

    • Shake well, wet hair, massage onto scalp and rinse.
    • For best results, use at least twice a week or as directed by a doctor.
  • Other Information

    Store at Room Temperature

  • Inactive Ingredients

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

  • Questions or comments ?

    1-877-846-9949

  • PDP03

    PDP03

  • INGREDIENTS AND APPEARANCE
    CAREONE MEDICATED DANDRUFF 
    selenium sulfide shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-025
    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)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MENTHOL (UNII: L7T10EIP3A)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    WATER (UNII: 059QF0KO0R)  
    TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
    AMMONIUM CHLORIDE (UNII: 01Q9PC255D)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72476-025-03325 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/26/2021
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H08/26/2021
    Labeler - Retail Business Services, LLC (967989935)
    Registrant - Apollo Health and Beauty Care (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Spa Dent Inc203478896manufacture(72476-025)