Diflorasone Diacetate

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

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

Pregnancy Category C Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

The following local adverse reactions have been reported with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in approximate decreasing order of occurrence: 1. Burning 2. Itching 3. Irritation 4. Dryness 5. Folliculitis 6. Hypertrichosis 7. Acneiform eruptions 8. Hypopigmentation 9. Perioral dermatitis 10. Allergic contact dermatitis 11. Maceration of the skin 12.

Secondary infection 13. Skin atrophy 14. Striae 15. Miliaria To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharmaceuticals, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.