Label: WALGREENS DANDRUFF AND CONDITIONER CLEANSING AND CONDITIONING 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 12, 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, distearyl phthalic acid amide, ammonium laureth sulfate, cocamide MEA, dimethicone, hydroxypropyl methylcellulose, fragrance, citric acid, sodium citrate, sodium chloride, phenoxyethanol, sodium xylenesulfonate, methylchloroisothiazolinone, methylisothiazolinone.

  • 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®††

    CLEANSING
    & CONDITIONING

    Dandruff
    Shampoo &
    Conditioner

    SELENIUM SULFIDE 1%

    2 in 1

    • Maximum strength formulation
    • With conditioner to help protect
      & strengthen damaged-looking hair
    • Formulated to help prevent
      & eliminate itchy scalp
      & visible flakes*

    11 FL OZ (325 mL)

    05-4490

    PRINCIPAL DISPLAY PANEL - 325 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    WALGREENS DANDRUFF AND CONDITIONER CLEANSING AND CONDITIONING   ANTI-DANDRUFF
    selenium sulfide shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-4136
    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)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Sodium Xylenesulfonate (UNII: G4LZF950UR)  
    Methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-4136-01325 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/03/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H01/03/2023
    Labeler - Walgreen Company (008965063)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries, INC255106239MANUFACTURE(0363-4136)
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