Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Fluocinonide Topical Solution USP, 0.05% is a clear, colorless to pale yellow solution supplied in plastic squeeze bottle: 60 mL - NDC 70752-154-05 Tamper Evident - Do not use if shrink seal is broken or missing Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature. Avoid excess heat, above 40°C (104°F). Manufactured by: Quagen Pharmaceuticals LLC West Caldwell, NJ 07006 52037 Rev. 04/25; PRINCIPAL DISPLAY PANEL NDC 70752- 154 -05 Fluocinonide Topical Solution, USP 0.05% Rx only 60 mL icarton60ml containerlabel60ml
- HOW SUPPLIED Fluocinonide Topical Solution USP, 0.05% is a clear, colorless to pale yellow solution supplied in plastic squeeze bottle: 60 mL - NDC 70752-154-05 Tamper Evident - Do not use if shrink seal is broken or missing Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature. Avoid excess heat, above 40°C (104°F). Manufactured by: Quagen Pharmaceuticals LLC West Caldwell, NJ 07006 52037 Rev. 04/25
- PRINCIPAL DISPLAY PANEL NDC 70752- 154 -05 Fluocinonide Topical Solution, USP 0.05% Rx only 60 mL icarton60ml containerlabel60ml
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 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: Fluocinonide topical solution USP, 0.05% contains fluocinonide 0.5 mg/mL in a clear, colorless to pale yellow solution of alcohol (35%), citric acid anhydrous, diisopropyl adipate, and propylene glycol. chemstruc
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 Miliaria To report SUSPECTED ADVERSE REACTIONS, contact Quagen Pharmaceuticals LLC. at 1-888-344-9603 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch for voluntary reporting of adverse reactions.
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