Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Fluocinonide Topical Solution USP, 0.05% is supplied in 60mL HDPE Bottle– NDC 40032-026-06 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Avoid excessive heat, above 40°C (104°F). Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 PI0260600101 Iss. 09/2016; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Fluocinonide Topical Solution USP, 0.05% Container Label Carton Label container carton
- HOW SUPPLIED Fluocinonide Topical Solution USP, 0.05% is supplied in 60mL HDPE Bottle– NDC 40032-026-06 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Avoid excessive heat, above 40°C (104°F). Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 PI0260600101 Iss. 09/2016
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Fluocinonide Topical Solution USP, 0.05% Container Label Carton Label container carton
Overview
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-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)-. It has the following chemical structure: Fluocinonide Topical Solution USP, 0.05% contains fluocinonide 0.5 mg/mL in a solution of citric acid, ethyl alcohol (35%), diisopropyl adipate, propylene glycol and purified water. In this formulation, the active ingredient is totally in solution. Structure
Indications & Usage
Fluocinonide Topical Solution USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage & 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.
Warnings & Precautions
No warnings available yet.
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 Hypertrichosis Maceration of the skin Itching Acneiform eruptions Secondary infection Irritation Hypopigmentation Skin atrophy Dryness Perioral dermatitis Striae Folliculitis Allergic contact dermatitis Miliaria
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