Label: WALGREENS DANDRUFF CONDITIONER 2 IN 1 ITCHY SCALP 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 April 3, 2023

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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, sodium lauryl sulfate, glycol distearate, sodium chloride, sodium xylenesulfonate, cocamidopropyl betaine, dimethicone, fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, pyrus malus (apple) juice, glycerin, sodium metabisulfite, citric acid, methylchloroisothiazolinone, methylisothiazolinone, yellow 5, blue 1.

  • Questions or Comments?

    1-800-925-4733

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 400 mL Bottle Label

    Walgreens

    Compare to the active ingredient
    in Head & Shoulders®††

    • WALGREENS •
    PHARMACIST RECOMMENDED†

    Dandruff
    Shampoo &
    Conditioner
    PYRITHIONE ZINC 1%

    2 in 1

    • Fresh clean scent
    • Helps improve the
      health of hair & scalp
    • Paraben free

    05-4462

    13.5 FL OZ (400 mL)

    PRINCIPAL DISPLAY PANEL - 400 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    WALGREENS DANDRUFF CONDITIONER 2 IN 1 ITCHY SCALP   ANTI-DANDRUFF
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-4288
    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)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Glycol Distearate (UNII: 13W7MDN21W)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Sodium Xylenesulfonate (UNII: G4LZF950UR)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    Magnesium Carbonate Hydroxide (UNII: YQO029V1L4)  
    APPLE JUICE (UNII: 9871T0PD5P)  
    Glycerin (UNII: PDC6A3C0OX)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorGREENScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-4288-01400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/22/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H12/22/2022
    Labeler - Walgreen Company (008965063)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries, INC255106239MANUFACTURE(0363-4288)
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