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 TypeHUMAN OTC DRUGItem Code (Source)NDC:51545-220
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
COAL TAR (COAL TAR) COAL TAR0.025 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage Description
1NDC:51545-220-12355 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart358H11/01/2009
Labeler - Ultimark Products LLC (964734078)

Revised: 08/2012
 
Ultimark Products LLC