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

INDICATIONS AND USAGE

Indication

OLUX-E^® Foam is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years and older.

Limitations of Use

• OLUX-E Foam should not be applied to the face, axillae, or groin.
• OLUX-E Foam should not be used if there is skin atrophy at the treatment site.
• Treatment should be limited to 2 consecutive weeks and patients should not use greater than 50 grams or more than 21 capfuls per week.

DOSAGE AND ADMINISTRATION

OLUX-E Foam is not for oral, ophthalmic, or intravaginal use.

Apply a thin layer of OLUX-E Foam to the affected area(s) twice daily, morning and evening for up to 2 consecutive weeks; therapy should be discontinued when control has been achieved. The maximum weekly dose should not exceed 50 g or an amount greater than 21 capfuls per week. For proper dispensing of foam, shake the can, hold it upside down, and depress the actuator. Dispense a small amount of foam (about a capful) 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.

DOSAGE FORMS AND STRENGTHS

Foam, 0.05%. Each gram of OLUX E Foam contains 0.5 mg of clobetasol propionate in a white to off-white petrolatum-based emulsion aerosol foam.

HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

OLUX-E (clobetasol propionate) Foam, 0.05% is a white to off-white aerosol foam supplied as follows:

• 50-g aluminum can             NDC 40076-101-50
• 100-g aluminum can            NDC 40076-101-00