Fluocinolone Acetonide Topical

Generic Name: fluocinolone acetonide topical

Corticosteroid [EPC]Over-the-Counter (OTC)

Brand Names:

Fluocinolone Acetonide Topical

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)-.

Overview

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)-.

Uses

INDICATIONS AND USAGE Fluocinolone acetonide topical solution is indicated for the relief of the inflammatory and pruritic manifestations of corticosteriod-responsive dermatoses.

Dosage

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.

Side Effects

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.

Warnings

CONTRAINDICATIONS Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Storage

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

Frequently Asked Questions

What is Fluocinolone Acetonide Topical used for?

INDICATIONS AND USAGE Fluocinolone acetonide topical solution is indicated for the relief of the inflammatory and pruritic manifestations of corticosteriod-responsive dermatoses.

What are the side effects of Fluocinolone Acetonide Topical?

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.

What are the important warnings for Fluocinolone Acetonide Topical?

CONTRAINDICATIONS Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.