Drug Facts
Composition & Profile
Identifiers & Packaging
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; Principal Display Panel NDC 0713-0223-15 Fluocinolone Acetonide Cream USP 0.01% 15 g FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only Cosette Pharmaceuticals, Inc. NDC 0713-0223-60 Fluocinolone Acetonide Cream USP 0.01% 60 g FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only Cosette Pharmaceuticals, Inc. carton-15-223 carton-60-223; Principal Display Panel NDC 0713-0224-15 Fluocinolone Acetonide Ointment, USP 0.025% 15 g FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only Cosette Pharmaceuticals, Inc. NDC 0713-0224-60 Fluocinolone Acetonide Ointment, USP 0.025% 60 g FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only Cosette Pharmaceuticals, Inc. 224-carton-15g 224-carton-60g
- 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
- Principal Display Panel NDC 0713-0223-15 Fluocinolone Acetonide Cream USP 0.01% 15 g FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only Cosette Pharmaceuticals, Inc. NDC 0713-0223-60 Fluocinolone Acetonide Cream USP 0.01% 60 g FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only Cosette Pharmaceuticals, Inc. carton-15-223 carton-60-223
- Principal Display Panel NDC 0713-0224-15 Fluocinolone Acetonide Ointment, USP 0.025% 15 g FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only Cosette Pharmaceuticals, Inc. NDC 0713-0224-60 Fluocinolone Acetonide Ointment, USP 0.025% 60 g FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only Cosette Pharmaceuticals, Inc. 224-carton-15g 224-carton-60g
Overview
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
Indications & Usage
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage & Administration
Topical corticosteroids are 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. 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 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, 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 .
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