Olux-E (Clobetasol Propionate Topical) - Indications and Dosage

INDICATIONS AND USAGE

Olux-E Foam is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years of age or older (see PRECAUTIONS). Treatment should be limited to 2 consecutive weeks and patients should not use greater than 50 grams per week (see DOSAGE AND ADMINISTRATION).

Patients should be instructed to use Olux-E Foam for the minimum amount of time necessary to achieve the desired results (see PRECAUTIONS).

Use in pediatric patients under 12 years of age is not recommended because of numerically high rates of hypothalamic-pituitary-adrenal (HPA) axis suppression seen in patients under 12 years of age (see PRECAUTIONS: Pediatric Use).

DOSAGE AND ADMINISTRATION

Apply a thin layer of Olux-E Foam to the affected area(s) twice daily, morning and evening. For proper dispensing of foam, shake the can, hold it upside down, and depress the actuator. Dispense a small amount of foam (not more than a dollop the size of a golf ball) and gently massage the medication into the affected areas (excluding the face, groin, and axillae) until the foam is absorbed. Avoid contact with the eyes.

Treatment should be limited to 2 consecutive weeks and patients should not use greater than 50 grams per week or an amount greater than 21 capfuls per week.

Therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Unless directed by a physician, Olux-E Foam should not be used with occlusive dressings.

HOW SUPPLIED

Olux-E (clobetasol propionate) Foam, 0.05% is supplied in 100 gram (NDC 63032-101-00) and 50 gram (NDC 63032-101-50) aluminum cans.

Store at controlled room temperature 68–77°F (20–25°C).

FLAMMABLE. AVOID FIRE, FLAME OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION.

 Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 120°F (49°C).

Avoid contact with eyes or other mucous membranes.

Keep out of reach of children.

Manufactured for

Stiefel Laboratories, Inc.

Coral Gables, FL 33134

USA

For additional information:

1-888-500-DERM or visit

www.olux-e.com

U.S. Patent No. 6,730,288

U.S. Patent No. 7,029,659

March 2007