DENOREX SEVERE ITCH- coal tar shampoo

Denorex Severe Itch by

Drug Labeling and Warnings

Denorex Severe Itch by is a Otc medication manufactured, distributed, or labeled by Neoteric Cosmetics, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients:

Coal Tar 1.8%
(from Coal Tar Topical Solution, USP 20%)

Purpose:

Anti-itch, anti-dandruff, anti-seborrheic dermatitis, anti-psoriasis

Uses:

Reduces and helps prevent recurrence of these symptoms of dandruff:

• scalp irritation and itching flaking scaling extra relief of itching due to dandruff

Warnings:

For external use only

Ask a doctor before use if you have

a condition covers a large area of the body.

When using this product

avoid contact with eyes. If contact occurs, rinse thoroughly with water

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:

• for best results, use at least twice a week or as directed by a doctor
• shake well before use
• apply to wet hair
• massage into scalp, leave lather on for several minutes
• rinse thoroughly and repeat for maximum relief

Other information

Store at 68-77°F (20-25°C)

Inactive ingredients

Aqua/Water/Eau, TEA Lauryl Sulfate, Alcohol, Cocamide DEA, PEG-30 Lanolin, Glycol Distearate, Fragrance/Parfum, Menthol, Panthenol, Persea Gratissima (Avocado) Oil, Helianthus Annuus (Sunflower) Seed Oil, Tocopheryl Acetate, Triethanolamine, PEG/PPG-4/12 Dimethicone, Hydroxypropyl Methylcellulose, Chloroxylenol, Polysorbate 80, Propylene Glycol, Quaternium 80, Ricinoleamidopropyl Ethyldimonium Ethosulfate, Citric Acid, Red 40

Questions?

Call 1-888-398-1382

email info@denorex.com or visit www.denorex.com

WARNING:

This product can expose you to chemicals including coal tar, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.

PRINCIPAL DISPLAY PANEL

ADVANCED RELIEF

Denorex®
SEVERE ITCH

MEDICATED

ANTI-DANDRUFF

SHAMPOO + CONDITIONER

1.8 % Coal Tar / DANDRUFF,

SEBORRHEIC DERMATITIS + PSORIASIS

INSTANT SOOTHING RELIEF

CONTROLS & RELIEVES:

SEVERE ITCHING

SCALP DISCOMFORT

INFLAMMATION

FLAKING & SCALING

associated with dandruff, seborrheic dermatitis + psoriasis

1.8% COAL TAR

10 FL OZ (296 mL)

INGREDIENTS AND APPEARANCE

DENOREX SEVERE ITCH 
coal tar shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62673-175
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

Inactive Ingredients
Ingredient Name	Strength
TRIETHANOLAMINE SULFATE (UNII: MV1V89M17O)
PEG/PPG-4/12 DIMETHICONE (UNII: JAN3585W85)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
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)
PANTHENOL (UNII: WV9CM0O67Z)
RICINOLEAMIDOPROPYL ETHYLDIMONIUM ETHOSULFATE (UNII: V176GWC2SR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
SUNFLOWER OIL (UNII: 3W1JG795YI)
PEG-30 LANOLIN (UNII: JSB8U68Q2U)
TROLAMINE (UNII: 9O3K93S3TK)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
QUATERNIUM-80 (UNII: C29NCR5LBE)
MENTHOL (UNII: L7T10EIP3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62673-175-10	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)