Label: DENOREX EXTRA STRENGTH- salicylic acid shampoo

  • NDC Code(s): 62673-059-10
  • Packager: Neoteric Cosmetics, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 7, 2024

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • ACTIVE INGREDIENTS

    Salicylic acid 3%

    (To the left)

  • PURPOSE

    Controls the symptoms of dandruff, seborrheic dermatitis and psoriasis

  • USES

    Reduces and helps eliminate scalp itching, flaking and scaling associated with dandruff, seborrheic dermatitis and psoriasis. Helps prevent recurrence of the symptoms of dandruff, seborrheic dermatitis and psoriasis

  • WARNINGS

    For external use only.

    ASK A DOCTOR BEFORE USE

    If you have a condition that covers a large area of body.

    WHEN USING THIS PRODUCT

    Avoid contact with the eyes. If contact occurs, rinse 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 THE REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    Shake well. Apply to wet hair. Gently massage into hair and scalp to work up a lather. Rinse thoroughly and repeat. For best results, use at least twice weekly or as directed by a doctor.

  • STORAGE

    Store at 68-77o F (20-25o C)

  • INACTIVE INGREDIENTS

    Sodium C14-C16 Olefin Sulfonate, Water, PPG-2 Hydroxyethyl Cocamide, Cocamidopropyl Betaine, Glycol Distearate, Propylene Glycol, Menthol, Polyquaternium-10, Panthenol (Provitamin B5),

    Fragrance, Vitamin E Acetate, Dimethicone, PEG-8 Meadowfoamate, Sodium Citrate, FD&C Yellow No. 6,

    D&C Yellow No. 10, D&C Red No. 33, FD&C Blue No. 1

    LEFT PANEL

    • GENTLE ENOUGH FOR REGULAR USE
    • CONDITIONS + MOISTURIZES
    • VITAMIN ENRICHED
    • STARTS WORKING IMMEDIATELY

    RIGHT PANEL

    QUESTIONS?

    1-800-552-5742

    VISIT US AT

    DENOREX.COM

    Manufactured by

    Neoteric Cosmetics, Inc.

    Denver, CO 80239

    MADE IN THE USA

  • PRINCIPAL DISPLAY PANEL

    Denorex

    EXTRA STRENGTH

    MEDICATED

    DANDRUFF SHAMPOO

    + CONDITIONER

    HELPS CONTROL DANDRUFF,

    SEBORRHEIC DERMATITIS + PSORIASIS

    CONTAINS 3% SALICYLIC ACID

    RELIEVES SCALP IRRITATION+ ITCHING

    CONTROLS FLAKING + SCALP BUILDUP

    10 FL OZ. (296 ml)

    PRINCIPAL DISPLAY PANEL Denorex EXTRA STRENGTH MEDICATED DANDRUFF SHAMPOO + CONDITIONER HELPS CONTROL DANDRUFF, SEBORRHEIC DERMATITIS + PSORIASIS CONTAINS 3% SALICYLIC ACID RELIEVES SCALP IRRITAT

  • INGREDIENTS AND APPEARANCE
    DENOREX EXTRA STRENGTH 
    salicylic acid shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62673-059
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.03 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    MENTHOL (UNII: L7T10EIP3A)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62673-059-10296 mL in 1 BOTTLE; Type 0: Not a Combination Product06/17/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03206/17/2019
    Labeler - Neoteric Cosmetics, Inc. (790615181)
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