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warnings
Warnings Use of topical corticosteroids, including diflorasone diactate dintment may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts have been reported in postmarketing experience with the use of topical diflorasone diacetate products. Glaucoma, with possible damage to the optic nerve, and increased intraocular pressure have been reported in postmarketing experience with the use of topical dermal corticosteroids. Avoid contact of Diflorasone Diacetate Ointment with eyes. Advise patients to report any visual symptoms.
Adverse Reactions The following local adverse reactions have been identified from clinical trials or postmarketing surveillance. Because they are reported from a population from unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to topical corticosteroids exposure. These adverse reactions may occur more frequently with the use of occlusive dressings or prolonged use of topical corticosteroids. Skin and Subcutaneous Tissue Disorders : burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. Vision Disorders: cataract, glaucoma, central serous chorioretinopathy To report SUSPECTED ADVERSE REACTIONS , contact Teligent Pharma, Inc. at 1-856-697-1441, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.