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Denorex Therapeutic by Ultimark Products LLC

Medically reviewed on December 13, 2017

Dosage form: shampoo
Ingredients: COAL TAR 0.018g in 1mL, MENTHOL 0.015g in 1mL
Labeler: Ultimark Products LLC
NDC Code: 51545-220

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.

Denorex Therapeutic

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)

DENOREX THERAPEUTIC 
coal tar and menthol 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 TAR0.018 g  in 1 mL
MENTHOL (MENTHOL) MENTHOL0.015 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
AVOCADO OIL 
CHLOROXYLENOL 
CITRIC ACID MONOHYDRATE 
FD&C RED NO. 40 
GLYCOL DISTEARATE 
HYPROMELLOSES 
LAURIC DIETHANOLAMIDE 
PANTHENOL 
RICINOLEAMIDOPROPYL ETHYLDIMONIUM ETHOSULFATE 
TRIETHANOLAMINE LAURYL SULFATE 
.ALPHA.-TOCOPHEROL ACETATE 
WATER 
Packaging
#Item CodePackage Description
1NDC:51545-220-12296 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H11/01/200907/31/2018
Labeler - Ultimark Products LLC (964734078)
Registrant - Humco Holding Group, Inc. (825672884)
Establishment
NameAddressID/FEIOperations
Humco Holding Group, Inc.825672884analysis(51545-220), manufacture(51545-220), pack(51545-220), label(51545-220)

 
Ultimark Products LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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