Fluocinonide

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

DOSAGE AND ADMINISTRATION Fluocinonide Topical Solution 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 the 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 preparation.

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 Itching Irritation Dryness Folliculitis Hypertrichosis Acneiform eruptions Hypopigmentation Perioral dermatitis Allergic contact dermatitis Maceration of the skin Secondary infection Skin atrophy Striae Miliaria To report SUSPECTED ADVERSE REACTIONS, contact Quagen Pharmaceuticals LLC. at 1-888-344-9603 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch for voluntary reporting of adverse reactions.

DESCRIPTION Fluocinonide topical solution 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-hydro xy-16 ,17-[(1- methylethylidene)bis(oxy)]-,(6 α, 11β, 16 α)-. It has the following chemical structure: Fluocinonide, USP is white or almost white microcrystalline powder. It is practically insoluble in water, very slightly soluble in ether, slightly soluble in ethanol, methanol and dioxane, sparingly soluble in acetone and chloroform. Fluocinonide topical solution USP, 0.05% contains fluocinonide USP, 0.5 mg/mL in a solution of citric acid monohydrate, dehydrated alcohol (35%), diisopropyl adipate, propylene glycol and purified water. In this formulation, the active ingredient is totally in solution. Fluocinonide topical solution USP, 0.5%

OVERDOSAGE Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS .) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc., at 1-886-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

HOW SUPPLIED Fluocinonide Topical Solution USP, 0.05% is clear solution free from particulate matter and is supplied as: NDC 70710-1284-8 in bottle of 20 mL NDC 70710-1284-3 in bottle of 60 mL Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat, above 40°C (104°F). Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Please address medical inquiries to, (MedicalAffairs@zydususa.com) Tel.: 1-877-993-8779.