Label: DENOREX EXTRA STRENGTH- 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 June 17, 2019

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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 IRRITATION+ ITCHING CONTROLS FLAKING + SCALP BUILDUP 10 FL OZ. (296 ml)

  • 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 FINALpart358H06/17/2019
    Labeler - Neoteric Cosmetics, Inc. (790615181)
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