Fluocinolone Acetonide Topical Solution USP, 0.01%

INDICATIONS AND 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 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.

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

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.jpg

OVERDOSAGE Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects ( See PRECAUTIONS ).

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°C to 25°C (59°F to 77°F); avoid freezing and excessive heat above 40°C (104°F). Store in an upright position. To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Product of Italy Manufactured by: Encube Ethicals Pvt. Ltd. Plot No. C1, Madkaim Industrial Estate, Madkaim, Post Mardol, Ponda, Goa-403 404, India. Distributed by: Encube Ethicals, Inc. 200 Meredith Drive, Suite 202 Durham, NC 27713 USA Rev: 07 February 2024