Betamethasone Dipropionate

INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

DOSAGE AND ADMINISTRATION: Apply a few drops of Betamethasone Dipropionate Lotion to the affected skin areas and massage lightly until it disappears. Apply twice daily, in the morning and at night. If an infection develops, appropriate antimicrobial therapy should be instituted. Betamethasone Dipropionate products should not be used with occlusive dressings.

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

ADVERSE REACTIONS: The following local adverse reactions are reported infrequently when Betamethasone Dipropionate products are used as recommended in the DOSAGE AND ADMINISTRATION section. 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 infections, skin atrophy, striae and miliaria. Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia and glucosuria in some patients. 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.