Drug Facts
Composition & Profile
Identifiers & Packaging
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; PRINCIPAL DISPLAY PANEL 60 mL
- 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
- PRINCIPAL DISPLAY PANEL 60 mL
Overview
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
Indications & Usage
Fluocinolone acetonide topical solution is indicated for the relief of the inflammatory and pruritic manifestations of corticosteriod-responsive dermatoses.
Dosage & 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.
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 Perioral dermatitis Itching Allergic contact dermatitis Irritation Maceration of the skin Dryness Secondary infection Folliculitis Skin atrophy Hypertrichosis Striae Acneiform eruptions Miliaria Hypopigmentation To report SUSPECTED ADVERSE EVENTS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda/gov/medwatch.
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