Label: CVS PHARMACY MAXIMUM STRENGTH DANDRUFF- selenium sulfide liquid

  • 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 July 19, 2017

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  • 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 if you have

    seborrheic dermatitis in areas other than the scalp.

    When using this product

    • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
    • for use on color 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, apply shampoo and 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 (Aqua), Sodium Laureth Sulfate, TEA-Lauryl Sulfate, Cocamidopropyl Betaine, Acrylates Copolymer, Citric Acid, Fragrance, Ammonium Chloride, Methylchloroisothiazolinone, Methylisothiazolinone, Menthol, Sodium Hydroxide, Magnesium Aluminum Silicate, Hydroxypropyl Methylcellulose, Blue 1 (CI 42090), Red 33 (CI 17200).

  • Label Copy

    Image of the label

  • INGREDIENTS AND APPEARANCE
    CVS PHARMACY  MAXIMUM STRENGTH DANDRUFF
    selenium sulfide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-719
    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)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    AMMONIUM CHLORIDE (UNII: 01Q9PC255D)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    MENTHOL (UNII: L7T10EIP3A)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-719-11325 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/18/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H07/18/2017
    Labeler - CVS Pharmacy (062312574)
    Registrant - Apollo Health and Beauty Care Inc. (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc.201901209manufacture(59779-719)
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