Extina (Ketoconazole Topical) - Indications and Dosage

INDICATIONS AND USAGE

Extina^® (ketoconazole) Foam, 2% is indicated for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older. Safety and efficacy of Extina Foam for treatment of fungal infections have not been established.

DOSAGE AND ADMINISTRATION

Extina Foam should be applied to the affected area(s) twice daily for four weeks.

Hold the container upright, and dispense Extina Foam into the cap of the can or other cool surface in an amount sufficient to cover the affected area(s). Dispensing directly onto hands is not recommended, as the foam will begin to melt immediately upon contact with warm skin. Pick up small amounts of Extina Foam with the fingertips, and gently massage into the affected area(s) until the foam disappears. For hair-bearing areas, part the hair, so that Extina Foam may be applied directly to the skin (rather than on the hair).

Avoid contact with the eyes and other mucous membranes. Extina Foam is not for ophthalmic, oral or intravaginal use.

DOSAGE FORMS AND STRENGTHS

Extina Foam contains 2% ketoconazole in a thermolabile hydroethanolic foam, and is provided in 50 g and 100 g aluminum containers (3. DOSAGE FORMS AND STRENGTHS).

HOW SUPPLIED/STORAGE AND HANDLING

Extina Foam, 2% is supplied in 50 g (NDC 63032-051-50) and 100 g (NDC 63032-051-00) aluminum containers.

Store at controlled room temperature 68°–77°F (20°-25°C). Do not store under refrigerated conditions. Do not expose containers to heat, and/or store at temperatures above 120^oF (49^oC). Do not store in direct sunlight.

Contents are flammable.

Contents under pressure. Do not puncture and/or incinerate container.

Keep out of reach of children.