DENOREX THERAPEUTIC- coal tar shampoo 
Ultimark Products LLC

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.

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Active Ingredients:

Coal tar solution 12.5% v/v (equivalent to 2.5% coal tar)

Purpose:

Controls dandruff, seborrheic dermatitis and psoriasis

Uses:

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

Warnings:

  • For external use only
  • Extremely flammable
  • Keep away from fire and flame
  • Cap bottle tightly and store at room temperature away from heat

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 before use
  • for best results, use at least twice a week or as directed by a doctor

Inactive ingredients

alcohol 10.4%, avocado oil, chloroxylenol, citric acid, dimethicone copolyol, FD&C red #40, fragrance, glycol distearate, hydroxypropyl methylcellulose, lauramide DEA, menthol, panthenol (provitamin B5), PEC-27 lanolin, quaternium-80, ricinoleamidopropyl ethyldimonium ethosulfate, TEA lauryl sulfate, vitamin E acetate, water

Questions?

1-800-443-4908

PRINCIPAL DISPLAY PANEL

Original
formula

THERAPEUTIC

DANDRUFF PROTECTION

Denorex

2-in-1

DANDRUFF

SHAMPOO +

CONDITIONER

12 FL OZ (355 mL)

PRINCIPAL DISPLAY PANEL
Original
formula
THERAPEUTIC
DANDRUFF PROTECTION
Denorex
2-in-1
DANDRUFF
SHAMPOO +
CONDITIONER
12 FL OZ (355 mL)

DENOREX THERAPEUTIC 
coal tar shampoo
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51545-220
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COAL TAR (COAL TAR) COAL TAR 0.025 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
AVOCADO OIL  
CHLOROXYLENOL  
CITRIC ACID MONOHYDRATE  
FD&C RED NO. 40  
GLYCOL DISTEARATE  
LAURIC DIETHANOLAMIDE  
MENTHOL  
PANTHENOL  
RICINOLEAMIDOPROPYL ETHYLDIMONIUM ETHOSULFATE  
TROLAMINE LAURYL SULFATE  
.ALPHA.-TOCOPHEROL ACETATE  
WATER  
Packaging
# Item Code Package Description
1 NDC:51545-220-12 355 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part358H 11/01/2009
Labeler - Ultimark Products LLC (964734078)

Revised: 08/2012
Ultimark Products LLC