fluocinolone acetonide

INDICATIONS AND USAGE Fluocinolone Acetonide Cream, USP is indicated for the relief of the inflammatory and pruritic mani­festations of corticosteriod-responsive dermatoses.

DOSAGE AND ADMINISTRATION Fluocinolone Acetonide Cream, USP 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. Some plastic films may be flammable and due care should be exer­cised in their use. Similarly, caution should be employed when such films are used on children or left in their proximity, to avoid the possibility of accidental suffocation. If an infection develops, the use of the 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, Itching, Irritation, Dryness, Folliculitis, Hypertrichosis, Acneiform eruptions, Hypopigmentation, Perioral dermatitis, Allergic contact dermatitis, Maceration of the skin, Secondary infection, Skin atrophy, Striae and Miliaria. To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

DESCRIPTION The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Fluocinolone Acetonide is included in this class of synthetic corticosteroids. Chemically Fluocinolone Acetonide is Pregna-1,4-diene-3,20-dione, 6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6α, 11β, 6α)-), with the molecular formula C 24 H 30 F 2 0 6 , a molecular weight of 452.49 and the following structural formula: Each gram of Fluocinolone Acetonide Cream, USP 0.01% contains 0.1 mg fluocinolone acetonide USP in a water washable cream base consisting of mineral oil (and) lanolin alcohols, isopropyl palmitate NF, propylene glycol stearate, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, purified water USP, propylene glycol USP with propylparaben NF and methylparaben NF as preservatives. Each gram of Fluocinolone Acetonide Ointment, USP 0.025% contains 0.25 mg of fluocinolone acetonide USP in an ointment base consisting of light mineral oil NF and white petrolatum USP. Chemical Structure

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

HOW SUPPLIED Fluocinolone Acetonide Cream, USP 0.01% is supplied in: 15 g tubes NDC 0713-0223-15, and 60 g tubes NDC 0713-0223-60 Fluocinolone Acetonide Ointment, USP 0.025% USP is supplied in: 15 g tubes NDC 0713-0224-15, and 60 g tubes NDC 0713-0224-60 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 VC7669 Rev. 09/2022 8-FLUOCPLNC3