Label: EQUATE MEDICATED DANDRUFF 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 January 10, 2022

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

View All Sections
  • 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

    As 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

  • QUESTIONS

    Satisfaction guaranteed - For questions or comments please call 1-888-287-1915.

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: Wal-Mart Stores, Inc.,
    Bentonville, AR 72716

  • PRINCIPAL DISPLAY PANEL - 325 mL Bottle Label

    NDC 49035-534-01

    equate™

    Compare to
    Selsun Blue®
    Medicated
    Dandruff
    Shampoo*

    Medicated

    Dandruff
    Shampoo

    With Menthol
    Selenium Sulfide 1%

    Controls Itching and Flaking
    Associated with Dandruff

    Helps Fight

    • Seborrheic Dermatitis
    • Dandruff

    11 FL OZ (325 mL)

    05-3698

    PRINCIPAL DISPLAY PANEL - 325 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    EQUATE MEDICATED DANDRUFF  ANTI-DANDRUFF
    selenium sulfide shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-534
    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:49035-534-01325 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/17/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H12/17/2018
    Labeler - Wal-Mart Stores, Inc. (051957769)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Garcoa, Inc.036464697MANUFACTURE(49035-534)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!