Fluocinonide
Cream · Topical
Uses
Fluocinonide Topical Solution USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage and administration
Fluocinonide Topical Solution USP, 0.05% is generally applied to the affected area as a thinfilm 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.
Contraindications
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Precautions
General Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitaryadrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, the addition of occlusive dressings, and dosage form. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. (See PRECAUTIONS - Pediatric Use .) This preparation is not for ophthalmic use. Severe irritation is possible if fluocinonide solution contacts the eye. If that should occur, immediate flushing of the eye with a large volume of water is recommended. If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. As with any topical corticosteroid product, prolonged use may produce atrophy of the skin and subcutaneous tissues. When used on intertriginous or flexor areas, or on the face, this may occur even with short-term use. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.
Side effects
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
Overdosage
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS ). To report SUSPECTED ADVERSE REACTIONS, contact Saptalis Pharmaceuticals, LLC. at 1-833-727-8254 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Description
FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only DESCRIPTION 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 solution of citric acid, ethyl alcohol (35%), diisopropyl adipate, propylene glycol and purified water. In this formulation, the active ingredient is totally in solution. fluocinonide01
How supplied
Fluocinonide Topical Solution USP, 0.05% is supplied in 20 mL (NDC 71656-094-20) and 60 mL (NDC 71656-094-60) bottles. Store at 20°- 25°C (68°- 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat, above 40°C (104°F). Distributed by: Saptalis Pharmaceuticals, LLC. Hauppauge, NY 11788 MADE IN USA Revised: 01/2026-R1
Label text from the FDA structured product label by Saptalis Pharmaceuticals, LLC. (revised May 11, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Fluocinonide in 52 products
Fluocinonide NDC products (52)
Fluocinonide recalls
- D-0475-2026 Apr 22, 2026 · Class II · Ongoing
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing. - D-0476-2026 Apr 22, 2026 · Class II · Ongoing
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing. - D-0477-2026 Apr 22, 2026 · Class II · Ongoing
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing. - D-0146-2018 Nov 1, 2017 · Class III · Terminated
Cross contamination with other products: traces of Dapsone were found in the finished product. - D-0790-2017 May 24, 2017 · Class III · Terminated
Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate.
Frequently asked questions
What is Fluocinonide used for?
Fluocinonide Topical Solution USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
What are the side effects of Fluocinonide?
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… See the full label for the complete list.
Who makes Fluocinonide?
Fluocinonide is listed by 24 labelers in the FDA NDC directory, including A-S Medication Solutions, Asclemed USA, Inc., Bryant Ranch Prepack, Cosette Pharmaceuticals, Inc..
Has Fluocinonide been recalled?
The FDA enforcement database lists 5 recalls for Fluocinonide, most recently D-0475-2026 (class ii): Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.