Psorent ® Psoriasis Topical Solution

Manufacturer
TriStrata, Inc. | Cosmetic Essence, LLC
Effective date
2019-05-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:23:26

Label at a glance#

ProductPsorent Psoriasis
Active ingredientCOAL TAR
Label structure11 sections

Indications and uses

Helps eliminate and prevent recurrence of these symptoms due to psoriasis: skin irritation itching flaking redness scaling

Dosage and administration

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...

Storage and handling

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Psoriasis Treatment

Uses

INDICATIONS & USAGE SECTION

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

  • skin irritation
  • itching
  • flaking
  • redness
  • scaling

Warnings

WARNINGS SECTION

For external use only

Flammable. Keep away from heat or flame.

Ask a doctor before use

OTC - ASK DOCTOR SECTION

  • 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

OTC - WHEN USING SECTION

  • 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)

OTC - STOP USE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

WARNINGS SECTION

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

INACTIVE INGREDIENT SECTION

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

Other information

STORAGE AND HANDLING SECTION

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?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL - 95 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL - 95 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 95 mL Bottle Carton

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71377-000171377-0001-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
60c744f1-38ff-4110-b037-4fc2e3d20067c4cce22e-db62-46ec-9c70-44879d5402a72019-05-24WarningsExact identifier
spl id: 60c744f1-38ff-4110-b037-4fc2e3d20067
spl set id: c4cce22e-db62-46ec-9c70-44879d5402a7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.