Topicort (Desoximetasone Topical) - Indications and Dosage

INDICATIONS AND USAGE

Topicort^® Topical Spray is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older.

DOSAGE AND ADMINISTRATION

Apply Topicort^® Topical Spray as a thin film to the affected skin areas twice daily. Rub in gently.

The treated skin area should not be bandaged or otherwise covered or wrapped unless directed by the physician.

Topicort^® Topical Spray should be discontinued when control is achieved.

Treatment beyond 4 weeks is not recommended.

Do not use if atrophy is present at the treatment site.

Avoid use on the face, axilla or groin.

Topicort^® Topical Spray is for external use only. It is not for oral, ophthalmic, or intravaginal use.

DOSAGE FORMS AND STRENGTHS

Topical Spray, 0.25%. Each gram of Topicort^® Topical Spray contains 2.5 mg of desoximetasone in a clear, colorless liquid.

HOW SUPPLIED/STORAGE AND HANDLING

How Supplied/Storage

Topicort^® (desoximetasone) Topical Spray, 0.25% is a clear colorless liquid supplied in white, opaque bottles with white, opaque screw caps in the following sizes:

• 30 mL (NDC 51672-5281-3)
• 50 mL (NDC 51672-5281-4)
• 100 mL (NDC 51672-5281-7)

Store at controlled room temperature between 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature] Spray is flammable; avoid heat, flame or smoking when using this product.

Each unit is co-packaged with a manual spray pump for installation by the pharmacist.

Instructions for the Pharmacist

• Remove the spray pump from the wrapper
• Remove and discard the cap from the bottle
• Keeping the bottle vertical, insert the spray pump into the bottle and turn clockwise until well-fastened
• Dispense the bottle with the spray pump inserted
• Label the bottle with "discard the product 30 days after dispensing"