DESOXIMETASONE

Desoximetasone Cream USP, 0.25% contains the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Each gram of Desoximetasone Cream USP, 0.25% contains 2.5 mg of desoximetasone in an emollient cream consisting of aluminum monostearate, cetostearyl alcohol, isopropyl myristate, lanolin alcohols, magnesium stearate, mineral oil, paraffin wax, purified water, and white petrolatum. The chemical name of desoximetasone is Pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16-methyl-,(11β,16α)-. Desoximetasone has the molecular formula C 22 H 29 FO 4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2. The chemical structure is: IAMGE 1

Desoximetasone Cream USP, 0.25% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Apply a thin film of Desoximetasone Cream USP, 0.25% to the affected skin areas twice daily. Rub in gently.

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria In controlled clinical studies, the incidence of adverse reactions was low (0.8%) for desoximetasone cream 0.25%, and included burning, folliculitis and folliculo-pustular lesions.

STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].