Drug Catalog - Product Detail
FLUOCINOLONE ACETONIDE TOPICAL SOLUTION .01% 60ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 21922-0003-01 | ENCUBE ETHICALS | 60 | 0.01% | NA |
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Description
DESCRIPTION Fluocinolone Acetonide Topical Solution, 0.01% is intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, 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, 0.01% contains fluocinolone acetonide 0.1 mg/mL in a water-washable base of anhydrous citric acid and propylene glycol. Structure
How Supplied
HOW SUPPLIED Fluocinolone Acetonide Topical Solution USP, 0.01% 60 mL Bottle with applicator tip NDC 21922-003-01 STORAGE: Store at room temperature 15-25°C (59-77°F); avoid freezing and excessive heat above 40°C (104°F). To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-866-495-2621 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured By: Encube Ethicals Pvt Ltd, Plot No. C1, Madkaim Ind. Estate, Madkaim, Post - Mardol, Ponda, Goa-403 404, India. Distributed By: Nivagen Pharmaceuticals, Inc. 3050 Fite Circle, Suite 100 Sacramento, California (CA) 95827, USA Rev: 02 Feb 2019
Indications & Usage
INDICATIONS & USAGE Fluocinolone Acetonide Topical Solution USP, 0.01% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage and Administration
DOSAGE & ADMINISTRATION Fluocinolone Acetonide Topical Solution USP, 0.01% 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 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.