Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Fluocinonide Topical Solution USP, 0.05% is supplied in: 60 mL bottles NDC 0168-0134-60. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Avoid excessive heat above 40°C (104°F). E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 I2134D R07/13 #49; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60mL CONTAINER NDC 0168-0134-60 FOUGERA ® FLUOCINONIDE TOPICAL SOLUTION USP, 0.05% 60 mL FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville, New York 11747 Fluocinonide Topl Soln USP, 0.05% Label; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60mL CARTON NDC 0168-0134-60 FOUGERA ® FLUOCINONIDE TOPICAL SOLUTION USP, 0.05% 60 mL FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville, New York 11747 Fluocinonide Topl Soln USP, 0.05% Carton 60mL
- HOW SUPPLIED: Fluocinonide Topical Solution USP, 0.05% is supplied in: 60 mL bottles NDC 0168-0134-60. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Avoid excessive heat above 40°C (104°F). E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 I2134D R07/13 #49
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60mL CONTAINER NDC 0168-0134-60 FOUGERA ® FLUOCINONIDE TOPICAL SOLUTION USP, 0.05% 60 mL FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville, New York 11747 Fluocinonide Topl Soln USP, 0.05% Label
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60mL CARTON NDC 0168-0134-60 FOUGERA ® FLUOCINONIDE TOPICAL SOLUTION USP, 0.05% 60 mL FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville, New York 11747 Fluocinonide Topl Soln USP, 0.05% Carton 60mL
Overview
Fluocinonide Topical Solution USP, 0.05% is intended for topical administration. The active component is the corticosteroid Fluocinonide, which is the 21-acetate ester of fluocinolone acetonide. The chemical name of Fluocinonide is 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 a molecular formula of C 26 H 32 F 2 O 7 and a molecular weight of 494.54. It has the following structural formula: Each mL of Fluocinonide Topical Solution USP, 0.05% contains: fluocinonide 0.5 mg in a solution of alcohol (35%), diisopropyl adipate, citric acid and propylene glycol. In this formulation, the active ingredient is totally in solution. chemical structure
Indications & Usage
: Fluocinonide Topical Solution USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage & Administration
: Fluocinonide Topical Solution 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, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.