Fluocinonide Ointment Recall
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Questions & Answers
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FDA Labeling Changes
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Fluocinonide Ointment USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
There is currently no drug history available for this drug.
Fluocinonide Ointment USP, 0.05% is intended for topical administration. The active component is the corticosteroid Fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6α,11β,16α)-. It has a molecular formula of C26H32F2O7 and a molecular weight of 494.53. It has the following structural formula:
Each gram of Fluocinonide Ointment USP, 0.05% contains fluocinonide 0.5 mg in a specially formulated ointment base consisting of glyceryl monostearate, white petrolatum, propylene carbonate, propylene glycol and white wax. It provides the occlusive and emollient effects desirable in an ointment. In this formulation, the active ingredient is totally in solution.