Psodex Psoriasis Cream Standard Therapy

Manufacturer
Psodex USA Inc.
Effective date
2021-01-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:49:54

Label at a glance#

ProductPsodex Psoriasis Cream Standard Therapy
Active ingredientCOAL TAR
Label structure8 sections

Dosage and administration

Apply to affected areas one to four times daily or as directed by a doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Coal Tar 0.5%

Purpose

OTC - PURPOSE SECTION

Psoriasis cream

Use

INDICATIONS & USAGE SECTION

Controls the symptoms of psoriasis

Warnings

WARNINGS SECTION

For external use only

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 up to 24 hours after application.

Do not use

OTC - DO NOT USE SECTION

  • For prolonged periods of time without consulting a doctor.
  • In or around the rectum or in the genital area or groin except on the advice of a doctor.
  • With other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed to by a doctor.

Ask a doctor before use if 

OTC - ASK DOCTOR SECTION

condition covers a large area of the body

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens or does not improve after regular use of this product as directed.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply to affected areas one to four times daily or as directed by a doctor.

Other information

SPL UNCLASSIFIED SECTION

Store at controlled room temperature 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Allantoin, Aloe Barbadensis Leaf Extract, Borage Seed Oil, Butyrospermum Parkii (Shea) Butter, Caprylic Capric Triglyceride, Caprylyl Glycol, Centella Asiatica Whole Extract, Cetearyl Alcohol, Cetearyl Olivate, Curcuma Longa Extract, D -Camphor Natural, D-Panthenol, Distilled Water, Ethylhexylglycerin, Frankincense Oil, Fumaria Officina is Extract, Genistein, Glycyrrhiza Glabra (Licorice) Root Extract, Mentha Piperita Leaf Extract, Pumpkin Seed Oil, Rosemary Leaf Oil, Salicylic Acid, Sorbitan Olivate, Stearic Acid, Tea Tree Leaf Oil, Vegetable Glycerin, Vitamin B3, Vitamin E, Zinc Acetate.

Questions or Comments?

OTC - QUESTIONS SECTION

1-844-PSODEXUSA info@psodexusa.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73503-00573503-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 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
b8b79fa3-2cc6-40aa-e053-2a95a90a96e4b8b79e8d-9c83-1700-e053-2995a90af5bd2021-01-12WarningsExact identifier
spl id: b8b79fa3-2cc6-40aa-e053-2a95a90a96e4
spl set id: b8b79e8d-9c83-1700-e053-2995a90af5bd

Reported adverse events (FAERS/openFDA)#

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