fluocinonide

INDICATIONS AND USAGE Fluocinonide Gel USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

DOSAGE AND ADMINISTRATION Fluocinonide Gel USP, 0.05% is generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

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

ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: Burning Hypertrichosis Maceration of the Skin Itching Acneiform Eruptions Secondary Infection Irritation Hypopigmentation Skin Atrophy Dryness Perioral Dermatitis Striae Folliculitis Allergic Contact Dermatitis Miliaria To report SUSPECTED ADVERSE REACTIONS , contact Padagis ® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DESCRIPTION Fluocinonide Gel 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)]-,(6a,11b,16a)-. It has the following chemical structure: Mol. Formula: C 26 H 32 F 2 O 7 Mol. Wt: 494.53 Fluocinonide Gel USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated gel base consisting of carbomer 980, edetate disodium, propyl gallate, propylene glycol, sodium hydroxide (to adjust pH) and purified water. This clear, colorless, thixotropic vehicle is greaseless, non-staining and completely water miscible. In the Fluocinonide Gel USP, 0.05% formulation, the active ingredient is totally in solution. fluocinonide chemical structure

OVERDOSAGE Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ).

HOW SUPPLIED Fluocinonide Gel USP, 0.05% is supplied in the following: 15 g (NDC 45802- 761 -15) 30 g (NDC 45802- 761 -30) and 60 g (NDC 45802- 761 -60) tubes. Store at 20°- 25°C (68°- 77°F) [see USP Controlled Room Temperature] Manufactured by Padagis®, Yeruham, Israel www.padagis.com Rev 08-24 7D000 RC PH2