DIFLORASONE DIACETATE

Diflorasone diacetate cream USP, 0.05% contains the active compound diflorasone diacetate, a synthetic corticosteroid for topical dermatological use. Chemically, diflorasone diacetate is 6α, 9α-difluoro-11β,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione 17,21 diacetate, with the empirical formula C 26 H 32 F 2 O 7 , a molecular weight of 494.5, and the following structural formula: Each gram of diflorasone diacetate cream USP, 0.05% contains 0.5 mg diflorasone diacetate in a cream base consisting of butylated hydroxytoluene, cetyl alcohol, citric acid, glyceryl stearate/PEG 100 stearate, isopropyl myristate, lanolin alcohol, mineral oil, monobasic sodium phosphate, polyoxyl 40 stearate, polysorbate 60, propylene glycol, purified water, sorbitan monostearate and vegetable oil. Chemical Structure

INDICATION AND USAGE Diflorasone diacetate cream USP, 0.05% is a high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Diflorasone diacetate cream USP, 0.05% should be applied to the affected area twice daily.

Diflorasone diacetate cream USP is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

The following local adverse reactions have been reported infrequently with other topical corticosteroids, and they may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infections, skin atrophy, striae, and miliaria. To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Store at 20 ° to 25 ° C (68 ° to 77 ° F) [see USP Controlled Room Temperature]. Keep tightly closed.