Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Fluocinonide Topical Solution USP, 0.05% is a clear transparent colorless solution supplied in plastic bottles. 60 mL-(NDC 21922-001-01) Tamper Evident - Do not use if shrink seal is broken or missing Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Avoid excess heat, above 40°C (104°F). Product of Italy; PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label NDC 21922-001-01 Fluocinonide Topical Solution USP, 0.05% For Topical Use Only. Not for ophthalmic use. Keep this and all medications out of the reach of children. Tamper Evident - Do not use if shrink seal is broken or missing 60 mL Rx only label; PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton NDC 21922-001-01 Fluocinonide Topical Solution USP, 0.05% For Topical Use Only. Not for opthalmic use. Keep this and all medications out of the reach of children. 60 mL Rx only carton
- HOW SUPPLIED Fluocinonide Topical Solution USP, 0.05% is a clear transparent colorless solution supplied in plastic bottles. 60 mL-(NDC 21922-001-01) Tamper Evident - Do not use if shrink seal is broken or missing Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Avoid excess heat, above 40°C (104°F). Product of Italy
- PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label NDC 21922-001-01 Fluocinonide Topical Solution USP, 0.05% For Topical Use Only. Not for ophthalmic use. Keep this and all medications out of the reach of children. Tamper Evident - Do not use if shrink seal is broken or missing 60 mL Rx only label
- PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton NDC 21922-001-01 Fluocinonide Topical Solution USP, 0.05% For Topical Use Only. Not for opthalmic use. Keep this and all medications out of the reach of children. 60 mL Rx only carton
Overview
Fluocinonide topical solution, 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 transparent solution of ethyl alcohol (35%),citric acid monohydrate,diisopropyl adipate, propylene glycol and purified water. Chemical Structure
Indications & Usage
Fluocinonide topical solution, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage & Administration
Fluocinonide topical solution, 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 Encube Ethicals Private. Limitd. at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Storage & Handling
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Avoid excess heat, above 40°C (104°F). Product of Italy
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