Label: WALGREENS DANDRUFF ITCHY DRY SCALP DEFENSE PLUS VITAMINS AND BOTANICALS ANTI-DANDRUFF- salicylic acid 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

    Salicylic Acid 3%

  • 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, cocamidopropyl betaine, PEG-10 sunflower glycerides, cocamide MEA, sodium methyl cocoyl taurate, fragrance, chamomilla recutita (matricaria) flower extract, lavandula angustifola (lavender) extract, rosmarinus officinalis (rosemary) leaf extract, acacia farnesiana flower extract, tocopheryl acetate, aloe barbadensis leaf juice, panthenol, sodium lauryl glucose carboxylate, lauryl glucoside, polyquaternium-10, linoleamidopropyl PG-dimonium chloride phosphate, sodium hydroxide, citric acid, disodium EDTA, sodium benzotriazolyl butylphenol sulfonate, isopropyl myristate, propylene glycol, sodium chloride, glycerin, phenoxyethanol, 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® Naturals††

    + Vitamins And Botanicals

    ITCHY DRY SCALP
    DEFENSE

    Dandruff
    Shampoo

    SALICYLIC ACID 3%

    • Daily scalp care
    • Made with vitamins B5 & E
      to promote healthy-looking hair
    • Formulated to help prevent
      & eliminate itchy scalp
      & visible flakes*

    11 FL OZ (325 mL)

    05-4488

    PRINCIPAL DISPLAY PANEL - 325 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    WALGREENS DANDRUFF ITCHY DRY SCALP DEFENSE PLUS VITAMINS AND BOTANICALS   ANTI-DANDRUFF
    salicylic acid shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-4137
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Ammonium Lauryl Sulfate (UNII: Q7AO2R1M0B)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    Sodium Methyl Cocoyl Taurate (UNII: JVL98CG53G)  
    CHAMOMILE (UNII: FGL3685T2X)  
    LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
    ROSEMARY (UNII: IJ67X351P9)  
    VACHELLIA FARNESIANA FLOWER (UNII: 8487B3MG6D)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Panthenol (UNII: WV9CM0O67Z)  
    Lauryl Glucoside (UNII: 76LN7P7UCU)  
    POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)  
    LINOLEAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: 5Q87K461JO)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM BENZOTRIAZOLYL BUTYLPHENOL SULFONATE (UNII: 0LA2QC9O3Z)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Glycerin (UNII: PDC6A3C0OX)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    Product Characteristics
    ColorYELLOWScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-4137-01325 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/05/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H01/05/2023
    Labeler - Walgreen Company (008965063)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries, INC255106239MANUFACTURE(0363-4137)
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