Drug Catalog - Product Detail
FLUOCINONIDE 0.05% GEL 60GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 47781-0533-26 | ALVOGEN | 60 | 0.05% | GEL |
PACKAGE FILES
Generic Name
FLUOCINONIDE GEL
Substance Name
FLUOCINONIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
NDA017373
Description
DESCRIPTION Fluocinonide Gel, 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 Gel contains fluocinonide 0.5 mg/g in a specially formulated gel base consisting of carbomer 940, edetate disodium, propyl gallate, propylene glycol, sodium hydroxide (to adjust the pH), and water (purified). This clear, colorless, thixotropic vehicle is greaseless, non-staining and completely water miscible. In this formulation, the active ingredient is totally in solution. Chemical Structure
How Supplied
HOW SUPPLIED Fluocinonide Gel, 0.05% is supplied in: 15 g Tube - NDC 47781-533-72 30 g Tube - NDC 47781-533-73 60 g Tube - NDC 47781-533-26 Store at room temperature 15°–30°C (59°–86°F).
Indications & Usage
INDICATIONS AND USAGE Fluocinonide Gel is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage and Administration
DOSAGE AND ADMINISTRATION Fluocinonide Gel 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 dressing 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.