INDICATIONS AND USAGE Desonide Cream, 0.05% is a low potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

It should not be used for longer than two weeks unless directed by a physician.

ADVERSE REACTIONS In controlled clinical trials, the total incidence of adverse reactions associated with the use of Desonide Cream, 0.05% was approximately 1%.

These adverse reactions were pruritus, pain, folliculitis, rash, peripheral edema, pustular rash, sweating, erythema, irritation, and burning.

Laboratory abnormalities were found in 3% of the patients.

These were hyperglycemia (2%) and liver function abnormality (1%).

The following additional local adverse reactions have been reported infrequently with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids.

These reactions are listed in approximate decreasing order of occurrence: dryness, folliculitis, acneiform eruptions, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, miliaria, burning and hypopigmentation.

To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc.

at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .