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Denorex Extra Strength (Ultimark Products LLC)

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Dosage Form Package Information Links
SHAMPOO 296 mL in 1 BOTTLE (51545-210-12) Label Information

Complete Denorex Extra Strength Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active Ingredients:

    Salicylic acid 3%


  • 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 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 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

  • Other information

    Store at 20º-25º C (68º – 77º F)


  • Inactive ingredients

    cocamidopropyl betaine, D&C Red No. 33, D&C Yellow No. 10, dimethicone PEG-8 meadowfoamate, FD&C Blue No. 1, FD&C Yellow No. 6, fragrance, glycol distearate, menthol, panthenol, polyquaternium-10, PPG-2 hydroxyethyl cocamide, propylene glycol, sodium C14-C16 olefin sulfonate, sodium citrate, vitamin E acetate, water


  • Questions?

    1-800-220-0151

    www.denorex.net


  • PRINCIPAL DISPLAY PANEL

    EXTRA STRENGTH DENOREX
    3 % Salicylic Acid

    DANDRUFF
    Control
    SHAMPOO +

    CONDITIONER

    10 FL OZ (296
    mL)

    EXTRA STRENGTH DENOREX
3 % Salicylic Acid
DANDRUFF Control
SHAMPOO +
CONDITIONER
10 FL OZ (296 mL)


  • INGREDIENTS AND APPEARANCE
    DENOREX EXTRA STRENGTH 
    salicylic acid shampoo
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51545-210
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.03 g  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51545-210-12 296 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2009 11/30/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part358H 11/01/2009 11/30/2018
    Labeler - Ultimark Products LLC (964734078)
    Registrant - Humco Holding Group, Inc. (825672884)
    Establishment
    Name Address ID/FEI Business Operations
    Humco Holding Group, Inc 825672884 manufacture(51545-210) , analysis(51545-210) , pack(51545-210) , label(51545-210)