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Denorex Therapeutic (Ultimark Products LLC)

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SHAMPOO 296 mL in 1 BOTTLE (51545-220-12) Label Information

Complete Denorex Therapeutic Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active Ingredients:

    Coal tar solution 9.0% v/v (equivalent to 1.8% coal tar)


  • Purpose:

    Controls the symptoms of dandruff, seborrheic dermatitis and psoriasis


  • Active Ingredients:

    Menthol 1.5%


  • Purpose:

    Controls scalp itch


  • Uses:

    • relieves and helps stop the recurrence of scalp itching, irritation, redness, flaking and scaling associated with dandruff, seborrheic dermatitis and psoriasis
    • extra relief of itching due to dandruff

  • Warnings:

    For external use only

    Do not use:
    • for prolonged periods without consulting a doctor
    • this product with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed to do so by a doctor

    Ask a doctor before use if you have

    condition covers a large area of the body.

    When using this product:
    • avoid contact with the eyes. If contact occurs, rinse thoroughly with water.
    • use caution in exposing skin to sunlight after applying. It may increase your tendency to sunburn for up to 24 hours after application.

    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 a week or as directed by a doctor

  • Inactive ingredients

    alcohol 7.3%, avocado oil, chloroxylenol, citric acid, dimethicone copolyol, FD&C red #40, fragrance, glycol distearate, hydroxypropyl methylcellulose, lauramide DEA, panthenol (provitamin B5), PEG-30 lanolin, quaternium-80, ricinoleamidopropyl ethyldimonium ethosulfate, TEA lauryl sulfate, vitamin E acetate, water


  • Questions?

    1-800-443-4908 or www.denoraxshampoo.com


  • WARNING:

    This product contains a chemical known to the State of California to cause cancer.


  • PRINCIPAL DISPLAY PANEL

    THERAPEUTIC
    Denorex

    1.8 % Coal Tar; 1.5 % Menthol

    Maximum Itch Relief

    DANDRUFF

    S
    HAMPOO +
    CONDITIONER

    10 FL OZ (296
    mL)

    THERAPEUTIC
Denorex
1.8 % Coal Tar; 1.5 % Menthol 
Maximum Itch Relief 
DANDRUFF
SHAMPOO +
CONDITIONER
10 FL OZ (296 mL)


  • INGREDIENTS AND APPEARANCE
    DENOREX THERAPEUTIC 
    coal tar and menthol shampoo
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51545-220
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR 0.018 g  in 1 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.015 g  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL (UNII: 3K9958V90M)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    RICINOLEAMIDOPROPYL ETHYLDIMONIUM ETHOSULFATE (UNII: V176GWC2SR)  
    TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51545-220-12 296 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2009 07/31/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part358H 11/01/2009 07/31/2018
    Labeler - Ultimark Products LLC (964734078)
    Registrant - Humco Holding Group, Inc. (825672884)
    Establishment
    Name Address ID/FEI Business Operations
    Humco Holding Group, Inc. 825672884 analysis(51545-220) , manufacture(51545-220) , pack(51545-220) , label(51545-220)