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  5. Label Information: Denorex Therapeutic

FDA Label for Denorex Therapeutic

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS:
    2. PURPOSE:
    3. USES:
    4. WARNINGS:
    5. DO NOT USE:
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. WHEN USING THIS PRODUCT:
    8. STOP USE AND ASK A DOCTOR IF:
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS:
    11. INACTIVE INGREDIENTS
    12. QUESTIONS?
    13. WARNING:
    14. PRINCIPAL DISPLAY PANEL

Denorex Therapeutic Product Label

The following document was submitted to the FDA by the labeler of this product Neoteric Cosmetics, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients:



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

Menthol 1.5%


Purpose:



Controls the symptoms of dandruff, seborrheic dermatitis and psoriasis

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)

THERAPEUTICDenorex1.8 % Coal Tar; 1.5 % Menthol Maximum Itch Relief DANDRUFFSHAMPOO +CONDITIONER10 FL OZ (296 mL) - denorex therapeutic 01

THERAPEUTICDenorex1.8 % Coal Tar; 1.5 % Menthol Maximum Itch Relief DANDRUFFSHAMPOO +CONDITIONER10 FL OZ (296 mL) - denorex therapeutic 01


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