Label: CVS HEALTH MAXIMUM STRENGTH DANDRUFF ANTI-SEBORRHEIC DERMATITIS, ANTI-DANDRUFF- selenium sulfide shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 24, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Selenium sulfide 1%

  • Purpose

    Anti-Seborrheic Dermatitis, anti-dandruff

  • Use

    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 using this product 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 (1-800-222-1222) 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 lauryl sulfate, ammonium laureth sulfate, distearyl phthalic acid amide, cocamide MEA, fragrance, titanium dioxide, dimethicone, hydroxypropyl methylcellulose, citric acid, sodium lauroyl lactylate, aloe barbadensis leaf juice, sodium citrate, sodium chloride, phenoxyethanol, methylchloroisothiazolinone, methylisothiazolinone, blue 1, yellow 10, ext. violet 2.

  • Questions or comments?

    1-866-567-8600

  • SPL UNCLASSIFIED SECTION

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895

  • PRINCIPAL DISPLAY PANEL - 325 mL Bottle Label

    CVS
    Health®

    Compare to the active
    ingredient in Selsun
    Blue® Moisturizing
    Dandruff Shampoo*

    MAXIMUM STRENGTH

    Dandruff
    Shampoo

    SELENIUM SULFIDE 1%

    • For the relief of seborrheic
      dermatitis & dandruff symptoms
    • Helps control flakes & itching
    • For healthier-looking hair & scalp

    MOISTURIZING
    + ALOE

    • PARABEN
    PHTHALATE •
    FREE

    11 FL OZ (325 mL)

    05-4270

    PRINCIPAL DISPLAY PANEL - 325 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    CVS HEALTH MAXIMUM STRENGTH DANDRUFF  ANTI-SEBORRHEIC DERMATITIS, ANTI-DANDRUFF
    selenium sulfide shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-387
    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 Lauryl Sulfate (UNII: Q7AO2R1M0B)  
    AMMONIUM LAURETH-5 SULFATE (UNII: 43ZIH89I48)  
    DISTEARYL PHTHALAMIC ACID (UNII: 5552GSZ9LI)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Sodium Lauroyl Lactylate (UNII: 7243K85WFO)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-387-01325 mL in 1 BOTTLE; Type 0: Not a Combination Product08/28/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03208/28/2024
    Labeler - CVS Health (062312574)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    SV Labs Toronto Corporation203917476label(51316-387) , manufacture(51316-387) , pack(51316-387)
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