Label: WALGREENS DANDRUFF MAXIMUM STRENGTH 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 April 10, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Selenium Sulfide 1%

  • Purpose

    Anti-dandruff

  • Use

    helps prevent recurrence of flaking and itching associated with dandruff.

  • Warnings

    For external use only

    When using this product

    ♦
    avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

    Stop use and ask a doctor if

    ♦
    condition worsens or does not improve after regular use 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
    ♦
    wet hair
    ♦
    massage onto scalp
    ♦
    rinse
    ♦
    repeat if desired
    ♦
    for best results use at least twice a week or as directed by a doctor
    ♦
    for maximum dandruff control, use every time you shampoo.
  • 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?

    1-800-925-4733

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: WALGREEN CO. 200 WILMOT RD.,
    DEERFIELD, IL 60015

  • PRINCIPAL DISPLAY PANEL - 325 mL Bottle Label

    Walgreens

    • WALGREENS •
    PHARMACIST RECOMMENDED†

    Compare to the active ingredient
    in Selsun Blue®††

    MAXIMUM STRENGTH

    Dandruff
    Shampoo

    SELENIUM SULFIDE 1%

    Moisturizing + Aloe

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

    11 FL OZ (325 mL)

    05-4484

    PRINCIPAL DISPLAY PANEL - 325 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    WALGREENS DANDRUFF MAXIMUM STRENGTH   ANTI-DANDRUFF
    selenium sulfide shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-4139
    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)  
    DISTEARYL PHTHALAMIC ACID (UNII: 5552GSZ9LI)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    Glycerin (UNII: PDC6A3C0OX)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    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:0363-4139-01325 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/19/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H12/19/2022
    Labeler - Walgreen Company (008965063)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries, INC255106239MANUFACTURE(0363-4139)
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