Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Fluocinonide Cream, USP 0.05% (Emulsified Base) is supplied in 15 g (NDC 0713-0664-15), 30 g (NDC 0713-0664-31) and 60 g (NDC 0713-0664-60) tubes. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Do not refrigerate. Distributed by: Cosette Pharmaceuticals,Inc. South Plainfield, NJ 07080 VC7673 Rev. 09/2022 8-0664CPLNC3; PRINCIPAL DISPLAY PANEL NDC 0713-0664-15 Fluocinonide Cream,USP (Emulsified Base) 0.05% 15 g Rx only FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. NDC 0713-0664-31 Fluocinonide Cream,USP (Emulsified Base) 0.05 30 g Rx only FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. NDC 0713-0664-60 Fluocinonide Cream,USP (Emulsified Base) 0.05% 60 g Rx only FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. 15gm-carton 30gm-carton 60gm-carton
- HOW SUPPLIED Fluocinonide Cream, USP 0.05% (Emulsified Base) is supplied in 15 g (NDC 0713-0664-15), 30 g (NDC 0713-0664-31) and 60 g (NDC 0713-0664-60) tubes. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Do not refrigerate. Distributed by: Cosette Pharmaceuticals,Inc. South Plainfield, NJ 07080 VC7673 Rev. 09/2022 8-0664CPLNC3
- PRINCIPAL DISPLAY PANEL NDC 0713-0664-15 Fluocinonide Cream,USP (Emulsified Base) 0.05% 15 g Rx only FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. NDC 0713-0664-31 Fluocinonide Cream,USP (Emulsified Base) 0.05 30 g Rx only FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. NDC 0713-0664-60 Fluocinonide Cream,USP (Emulsified Base) 0.05% 60 g Rx only FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. 15gm-carton 30gm-carton 60gm-carton
Overview
Fluocinonide Cream, USP 0.05% (Emulsified Base) is intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6α ,11β,16α )-. It has the following chemical structure: Mol. Formula: C 26 H 32 F 2 O 7 Mol. Wt: 494.53 Fluocinonide Cream, USP 0.05% (Emulsified Base) contains fluocinonide 0.5 mg/g in a water-washable aqueous emollient base of cetyl alcohol, citric acid (anhydrous), mineral oil, polysorbate 60, propylene glycol, purified water, sorbitan monostearate, stearyl alcohol. molecular-structure
Indications & Usage
Fluocinonide Cream USP, 0.05% (Emulsified Base) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage & Administration
Fluocinonide Cream, USP 0.05% (Emulsified Base) is generally applied to the affected area as a thin film from two to four times daily, as needed. 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.
Warnings & Precautions
No warnings available yet.
Contraindications
Fluocinonide Cream, USP 0.05% is 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 Hypertrichosis Maceration of the Skin Itching Acneiform Eruptions Secondary Infection Irritation Hypopigmentation Skin Atrophy Dryness Perioral Dermatitis Striae Folliculitis Allergic Contact Dermatitis 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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