Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Fluocinonide Cream, USP 0.05% is supplied in 15 g (NDC 0713-0663-15), 30 g (NDC 0713-0663-31), and 60 g (NDC 0713-0663-60) tubes. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 Iss. 09/2021 8-0663CPLNC1 VC7594; PRINCIPAL DISPLAY PANEL NDC 0713- 0663 -15 Rx Only Fluocinonide Cream, USP 0.05% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. 15 g NDC 0713- 0663 -15 Rx Only Fluocinonide Cream, USP 0.05% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. 15 g NDC 0713- 0663 -31 Rx Only Fluocinonide Cream, USP 0.05% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. 30 g NDC 0713- 0663 -31 Rx Only Fluocinonide Cream, USP 0.05% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. 30 g NDC 0713- 0663 -60 Rx Only Fluocinonide Cream, USP 0.05% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. 60 g NDC 0713- 0663 -60 Rx Only Fluocinonide Cream, USP 0.05% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. 60 g 15 g label 0.05% 15 g carton 0.05% 30 g label 0.05% 30 g carton 0.05% 60 g label 0.05% 60 g carton 0.05%
- HOW SUPPLIED Fluocinonide Cream, USP 0.05% is supplied in 15 g (NDC 0713-0663-15), 30 g (NDC 0713-0663-31), and 60 g (NDC 0713-0663-60) tubes. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 Iss. 09/2021 8-0663CPLNC1 VC7594
- PRINCIPAL DISPLAY PANEL NDC 0713- 0663 -15 Rx Only Fluocinonide Cream, USP 0.05% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. 15 g NDC 0713- 0663 -15 Rx Only Fluocinonide Cream, USP 0.05% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. 15 g NDC 0713- 0663 -31 Rx Only Fluocinonide Cream, USP 0.05% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. 30 g NDC 0713- 0663 -31 Rx Only Fluocinonide Cream, USP 0.05% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. 30 g NDC 0713- 0663 -60 Rx Only Fluocinonide Cream, USP 0.05% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. 60 g NDC 0713- 0663 -60 Rx Only Fluocinonide Cream, USP 0.05% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. 60 g 15 g label 0.05% 15 g carton 0.05% 30 g label 0.05% 30 g carton 0.05% 60 g label 0.05% 60 g carton 0.05%
Overview
Fluocinonide Cream, USP 0.05% 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)]-, (6∝,11ß,16∝). Its molecular formula is C 26 H 32 F 2 O 7 , and has the molecular weight of 494.53. It has the following chemical structure: Fluocinonide Cream, USP 0.05% contains fluocinonide 0.5 mg/g in a cream base consisting of citric acid, 1,2,6-hexanetriol, polyethylene glycol-8000, propylene glycol and stearyl alcohol. This white cream vehicle is greaseless, non-staining, anhydrous and completely water miscible. The base provides emollient and hydrophilic properties. In the Fluocinonide Cream, USP 0.05% formulation, the active ingredient is totally in solution. structural formula
Indications & Usage
Fluocinonide Cream, USP 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage & Administration
Fluocinonide cream 0.05% is generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. 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 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, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, 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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