PSORENT PSORIASIS- coal tar liquid

Psorent Psoriasis by

Drug Labeling and Warnings

Psorent Psoriasis by is a Otc medication manufactured, distributed, or labeled by TriStrata, Inc., Cosmetic Essence, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Coal Tar 2.3% (from Coal Tar Topical Solution, USP 15%)

Purpose

Psoriasis Treatment

Uses

Helps eliminate and prevent recurrence of these symptoms due to psoriasis:

• skin irritation
• itching
• flaking
• redness
• scaling

Warnings

For external use only

Flammable. Keep away from heat or flame.

Ask a doctor before use

• for prolonged periods
• if condition covers a large area of the body
• in or around the rectum or in the genital area or groin
• with other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs
• on children under 2 years of age
• if you are pregnant or breastfeeding

When using this product

• avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
• use caution in exposing skin to sunlight after applying this product. It may increase your tendency to sunburn for up to 24 hours after application.
• use a sunscreen (minimum SPF 15)

Stop and ask a doctor if rash or irritation develops, or 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

• Read warnings before use
• Use only as directed
• Apply to scalp and/or skin one to two times daily or as directed by a doctor. If use on scalp is desired, test in a small, discrete spot first to make sure solution will not discolor hair.
• Invert bottle and gently dab onto affected skin to start the flow of medication. Application pad may already be wet upon initial opening.
• Apply just enough medication to wet the skin and avoid dripping
• Avoid applying to severely cracked or irritated areas
• Allow solution to fully dry before dressing to avoid staining clothing.
• Do not rinse off treated skin
• Cap bottle tightly after use

WARNING

This product can expose you to coal tar, a chemical known to the State of California to cause cancer. For more information, go to www.p65Warnings.ca.gov/product

Inactive ingredients

Alcohol Denat., Cyclohexasiloxane, Cyclopentasiloxane, Dioctyldodecyl Dodecanedioate, Oleth-2, Parfum (Fragrance), Polysorbate 80, Propylene Glycol, Triethyl Citrate.

Other information

Store upright at 15°-30°C (59°-86°F). Keep away from extreme heat, cold, and direct sunlight. Do not bring on an airplane, as leakage may occur in luggage. If the applicator becomes dirty or clogged, gently wipe with an alcohol pad. May stain your skin, hair, nails, clothing, and other household surfaces that come in contact with the medication. As with all topical medications, wash your hands after each application.

Questions or comments?

Call toll free 1-800-628-9904 (9am-5pm ET)

PRINCIPAL DISPLAY PANEL - 95 mL Bottle Carton

PSORENT®

Psoriasis
Topical Solution

The Power of a
Prescription

Safe and Easy to Apply

For mild to moderate Psoriasis

95 mL / 3.2 fl oz

INGREDIENTS AND APPEARANCE

PSORENT PSORIASIS 
coal tar liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71377-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC)	COAL TAR	23 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIOCTYLDODECYL DODECANEDIOATE (UNII: 7QDB5EE79Y)
OLETH-2 (UNII: 7L6R1SQ6M0)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71377-0001-1	1 in 1 CARTON	08/15/2017	03/31/2021
1		95 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358H	08/15/2017	03/31/2021

Labeler - TriStrata, Inc. (809571029)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Essence, LLC		032565959	MANUFACTURE(71377-0001)