Label: WALGREENS DANDRUFF PLUS CONDITIONER 2 IN 1 ANTI-DANDRUFF- pyrithione zinc 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 December 15, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts
  • Active ingredient

    Pyrithione Zinc 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, sodium laureth sulfate, cocamide MEA, sodium lauryl sulfate, glycol distearate, dimethicone, fragrance, cetyl alcohol, polyquaternium-10, guar hydroxypropyltrimonium chloride, magnesium sulfate, sodium benzoate, magnesium carbonate hydroxide, ammonium laureth sulfate, benzyl alcohol, sodium chloride, methylchloroisothiazolinone, methylisothiazolinone, sodium xylenesulfonate, citric acid, blue 1, red 4.

  • Questions or Comments?

    1-800-925-4733

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 1 L Bottle Label

    VALUE SIZE

    Walgreens

    Compare to the active ingredient in
    Head & Shoulders® Classic Clean 2-in-1
    Dandruff Shampoo + Conditioner††

    • WALGREENS •
    PHARMACIST RECOMMENDED†

    CLASSIC EVERYDAY CLEAN
    Dandruff
    Shampoo Plus
    Conditioner
    WITH PYRITHIONE ZINC

    2 in 1

    pH Balanced

    • Basic everyday
      cleaning &
      conditioning
    • Leaves hair feeling soft

    –NO–
    PARABENS
    PHTHALATES

    33.8 FL OZ (1 L)

    05-4495

    PRINCIPAL DISPLAY PANEL - 1 L Bottle Label
  • INGREDIENTS AND APPEARANCE
    WALGREENS DANDRUFF PLUS CONDITIONER 2 IN 1   ANTI-DANDRUFF
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-4673
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5) Pyrithione Zinc10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Sodium Laureth-3 Sulfate (UNII: BPV390UAP0)  
    Coco Monoethanolamide (UNII: C80684146D)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Glycol Distearate (UNII: 13W7MDN21W)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Polyquaternium-10 (30000 MPA.S at 2%) (UNII: C7RDC8Y4JS)  
    Guar Hydroxypropyltrimonium Chloride (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    Magnesium Sulfate, Unspecified Form (UNII: DE08037SAB)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Magnesium Carbonate Hydroxide (UNII: YQO029V1L4)  
    Ammonium Laureth-5 Sulfate (UNII: 43ZIH89I48)  
    Benzyl Alcohol (UNII: LKG8494WBH)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    Sodium Xylenesulfonate (UNII: G4LZF950UR)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Fd&C Blue No. 1 (UNII: H3R47K3TBD)  
    Fd&C Red No. 4 (UNII: X3W0AM1JLX)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-4673-011000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/05/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart358H12/05/2022
    Labeler - Walgreen Company (008965063)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan America, LLC964976968MANUFACTURE(0363-4673)
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