Label: LEADER THERAPEUTIC DANDRUFF ANTI-DANDRUFF, ANTI-SEBORRHEIC DEMATITIS AND ANTI-PSORIASIS- salicylic acid shampoo

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

Drug Label Information

Updated March 13, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic Acid 3.0%

  • Purpose

    Anti-dandruff, anti-seborrheic dermatitis and anti-psoriasis

  • Uses

    control the symptoms of

    ⬥
    dandruff
    ⬥
    seborrheic dermatitis
    ⬥
    psoriasis
  • Warnings

    For external use only

    Ask a doctor before use if you have a condition which covers a large area of the body.

    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 of this product 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

    ⬥
    for best results use at least twice a week or as directed by a doctor
    ⬥
    wet hair thoroughly
    ⬥
    massage shampoo into scalp
    ⬥
    lather, leave on hair and scalp for several minutes
    ⬥
    rinse and repeat.
  • Other information

    ⬥
    store at room temperature
    ⬥
    store away from direct sunlight.
  • Inactive ingredients

    water, sodium C14-16 olefin sulfonate, sodium laureth sulfate, cocamidopropyl betaine, cocamide MEA, PEG-150 distearate, polyquaternium-10, propylene glycol, sodium citrate, sodium hydroxide.

  • Questions or comments?

    1-866-567-8600

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY
    CARDINAL HEALTH
    DUBLIN, OHIO 43017

  • PRINCIPAL DISPLAY PANEL - 133 mL Bottle Label

    LEADER™

    NDC 70000-0550-1

    Therapeutic
    Dandruff
    Shampoo

    Salicylic Acid, 3%
    Anti-Dandruff
    Anti-Seborrheic Dermatitis
    Anti-Psoriasis

    Controls the
    Symptoms of Psoriasis,
    Seborrheic Dermatitis
    & Dandruff
    Clears & Helps Prevent
    Scalp Buildup
    Fragrance-Free
    Dye-Free
    Preservative-Free

    COMPARE TO
    NEUTROGENA® T/SAL®
    active ingredient*

    100% Money Back Guarantee

    4.5 FL OZ (133 mL)

    05-3791B

    Principal Display Panel - 133 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    LEADER THERAPEUTIC DANDRUFF   ANTI-DANDRUFF, ANTI-SEBORRHEIC DEMATITIS AND ANTI-PSORIASIS
    salicylic acid shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0550
    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)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    PEG-150 Distearate (UNII: 6F36Q0I0AC)  
    POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Product Characteristics
    ColorYELLOWScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0550-1133 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/30/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM03208/30/2022
    Labeler - Cardinal Health (063997360)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries INC255106239MANUFACTURE(70000-0550)
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