DENOREX THERAPEUTIC- coal tar and menthol shampoo

Denorex Therapeutic by

Drug Labeling and Warnings

Denorex Therapeutic by is a Otc medication manufactured, distributed, or labeled by Neoteric Cosmetics, Inc., Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

DENOREX THERAPEUTIC 
coal tar and menthol shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62673-174
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: 62673-174-10	296 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/13/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	12/13/2017

Labeler - Neoteric Cosmetics, Inc. (790615181)

Registrant - Pharma Nobis, LLC (118564114)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Nobis, LLC		118564114	manufacture(62673-174) , analysis(62673-174) , pack(62673-174) , label(62673-174)