Label: NIZORAL PSORIASIS- salicylic acid shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 18, 2024

If you are a consumer or patient please visit this version.

  • Active ingredient

    Salicylic Acid 3%

  • Purpose

    Psoriasis and Seborreic Dermatitis

  • Uses

    Relieves and helps prevent recurrence of scalp:

    irritation

    itching

    redness

    flaking

    scaling due to psoriasis and seborreic dermatitis

  • WARNINGS

    For external use only

    Ask a doctor before use if

    you have psoriasis that covers a large area of the body

    if you are allergic to ingredients in this product

    When using this product

    avoid contact with eyes

    If contact occurs, rinse eyes thoroughly with water

    Keep out of reach of children.

    if swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    for best results use at least twice a week or as directed by a doctor
    wet hair thoroughly
    massage liberal amount of product into scalp
    leave lather on for several minutes
    rinse thoroughly and repeat if needed

  • Other information

    store between 20° – 25°C (68° – 77°F)

  • Inactive ingredients

    Ascorbic Acid, Cocamidopropyl Betaine, DL Panthenol USP Powder, Green Tea Extract,
    Linolemidopropyl PG-Dimonium Chloride Phosphate, PEG-120 Methyl Glucose Dioleate,
    Polyquaternium-7, Propylene Glycol, Puried Water, Sodium C-14-16 Olefin Sulfonate, Tea
    Tree Oil, Trolamine, Vitamin E Acetate

  • Questions or comments?

    Call 800-824-4894

  • SPL UNCLASSIFIED SECTION

  • label

    labellabel

  • INGREDIENTS AND APPEARANCE
    NIZORAL PSORIASIS 
    salicylic acid shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44038-0202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    TEA TREE OIL (UNII: VIF565UC2G)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    LINOLEAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: 5Q87K461JO)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44038-0202-11 in 1 CARTON12/01/2020
    1325 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03212/01/2020
    Labeler - Accupac LLC (071609663)
    Registrant - Accupac LLC (061595175)