Drug Catalog - Product Detail
FLUOCINOLONE ACETONIDE TOP SOL 0.01% 60ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00591-2990-60 | ACTAVIS PHARMA | 60 | 0.01% | NA |
PACKAGE FILES
Generic Name
FLUOCINOLONE ACETONIDE TOPICAL
Substance Name
FLUOCINOLONE ACETONIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA208386
Description
DESCRIPTION Fluocinolone acetonide topical solution, USP 0.01% is intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, USP, which has the chemical name pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis (oxy)]-,(6α,11β,16α)-. It has the following chemical structure: Fluocinolone acetonide topical solution, USP contains fluocinolone acetonide, USP (anhydrous) 0.1 mg/mL in a water-washable base of citric acid anhydrous and propylene glycol. formula
How Supplied
HOW SUPPLIED Fluocinolone Acetonide) Topical Solution, 0.01% 60 mL Bottle with applicator tip – NDC 0591-2990-60 STORAGE Store at room temperature 15° to 25°C (59° to 77°F); avoid freezing and excessive heat above 40°C (104°F). Manufactured by: Actavis Laboratories UT, Inc. Salt Lake City, UT 84108 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA 234192-00 Revised – August 2016
Indications & Usage
INDICATIONS AND USAGE Fluocinolone acetonide topical solution is indicated for the relief of the inflammatory and pruritic manifestations of corticosteriod-responsive dermatoses.
Dosage and Administration
DOSAGE AND ADMINISTRATION Fluocinolone acetonide topical solution is generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. In hairy sites, the hair should be parted to allow direct contact with the lesion. 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.