Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Fluocinonide Cream USP, 0.05% is supplied in 15 g (NDC 51672-1386-1), 30 g (NDC 51672-1386-2), 60 g (NDC 51672-1386-3) and 120 g (NDC 51672-1386-4) tubes. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].; PRINCIPAL DISPLAY PANEL - 15 g Tube Carton NDC 51672-1386-1 Fluocinonide Cream USP, 0.05% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. 15 g Rx only Keep this and all medications out of the reach of children. TARO PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
- HOW SUPPLIED Fluocinonide Cream USP, 0.05% is supplied in 15 g (NDC 51672-1386-1), 30 g (NDC 51672-1386-2), 60 g (NDC 51672-1386-3) and 120 g (NDC 51672-1386-4) tubes. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
- PRINCIPAL DISPLAY PANEL - 15 g Tube Carton NDC 51672-1386-1 Fluocinonide Cream USP, 0.05% FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. 15 g Rx only Keep this and all medications out of the reach of children. TARO PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
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)]-,(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% contains fluocinonide 0.5 mg/g in a specially formulated cream base consisting of citric acid, glycerin, 1,2,6-hexanetriol, polyethylene glycol-3350, 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 hydrophylic properties. In the Fluocinonide Cream USP, 0.05% formulation, the active ingredient is totally in solution. Chemical Structure
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 USP, 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
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 Hypertrichosis Maceration of the Skin Itching Acneiform Eruptions Secondary Infection Irritation Hypopigmentation Skin Atrophy Dryness Perioral Dermatitis Striae Folliculitis Allergic Contact Dermatitis Miliaria
Storage & Handling
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
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