Fluocinonide .5 mg/mL Solution
Other active recalls for Fluocinonide (different manufacturers) — 3 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Corticosteroid class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Fluocinolone topical is used to treat the itching, redness, dryness, crusting, scaling, inflammation, and discomfort of various skin conditions, including psoriasis (a skin disease in which red, scaly patches form on some areas of the body and eczema (a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes). Fluocinolone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.
Read the full MedlinePlus article ↗- Fluocinonide is used to calm inflamed, itchy skin — things like eczema (atopic dermatitis), psoriasis, and other inflammatory skin conditions that respond to steroid treatment. It...
- What skin problems does fluocinonide actually treat?
- Use a thin layer — just enough to cover the affected area — and rub it in gently. How often you apply it depends on your product and condition: some people use it once a day, other...
- That's a really common feeling with skin conditions, but with the 0.1% strength products, treatment beyond 2 consecutive weeks is generally not recommended because of the risk of t...
Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
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UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
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UNII P7E6YFV72X
Diisopropyl adipate is a clear, oily liquid derived from adipic acid. It acts as a plasticizer and solvent in medicines, helping soften coatings and improve how the drug dissolves or spreads in the body.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.316 | $6.33 / 20 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.6542 | $13.08 / 20 ml |
| Medicare drug plans payPart D · Q2 2026 | $0.4094 | $8.19 / 20 ml |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| fluocinonide .5 mg/mL 00168-0134-60 | E. | 1 bottle | $0.199 | AT | Availability likely | save 37% |
| Fluocinonide .5 mg/mL 21922-0001-01 | Encube | 1 bottle | $0.199 | AT | Availability likely | save 37% |
| Fluocinonide .5 mg/mL 70710-1284-03 | Zydus | 60 ml | $0.199 | AT | Availability likely | save 37% |
| Fluocinonide .5 mg/mL 70752-0154-05 | QUAGEN | 1 bottle | $0.199 | AT | Availability likely | save 37% |
| Fluocinonide .5 mg/mL 72603-0703-01 | NorthStar | 1 bottle | $0.199 | AT | Availability likely | save 37% |
| Fluocinonide .5 mg/mLthis 33342-0320-84 | Macleods | 1 bottle | $0.316 | AT | Availability likely | — |
| Fluocinonide .5 mg/mL 43386-0026-02 | Lupin | 1 bottle | $0.316 | AT | Availability likely | — |
| Fluocinonide .5 mg/mL 51672-1273-02 | Sun | 1 bottle | $0.316 | AT | Availability likely | — |
| fluocinonide .5 mg/mL 40032-0026-06 | Novel | 1 bottle | — | AT | FDA listed | — |
| Fluocinonide .5 mg/mL 63629-9583-01 | Bryant | 1 bottle | — | AT | FDA listed | — |
| Fluocinonide .5 mg/mL 68071-3918-06 | NuCare | 1 bottle | — | AT | FDA listed | — |
| Fluocinonide .5 mg/mL 70771-1375-03 | Zydus | 60 ml | — | AT | FDA listed | — |
| Fluocinonide .5 mg/mL 71656-0094-20 | Saptalis | 20 ml | — | AT | FDA listed | — |
| Fluocinonide .5 mg/mL 72162-1270-06 | Bryant | 1 bottle | — | AT | FDA listed | — |
| fluocinonide .5 mg/mL 72162-2146-06 | Bryant | 1 bottle | — | AT | FDA listed | — |
| Fluocinonide .5 mg/mL 72162-2490-02 | Bryant | 1 bottle | — | AT | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 33342-0320-84 You're viewing this | 1 BOTTLE in 1 CARTON (33342-320-84) / 20 mL in 1 BOTTLE | $0.3163 / mL | $6.33 | 2018-04-24 | Active |
| 33342-0320-85 | 1 BOTTLE in 1 CARTON (33342-320-85) / 60 mL in 1 BOTTLE | $0.1985 / mL | $11.91 | 2018-04-24 | Active |
Per mL, this pack runs about 59% above the cheapest pack (NDC 33342-0320-85, $0.1985 vs $0.3163 NADAC).
This pack accounts for about 2.5% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓
Pack size FAQ
What quantity is in NDC 33342-0320-84?
What NDC number is used to bill for this package of Fluocinonide .5 mg/mL Solution?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS & USAGE Fluocinonide Topical Solution USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
⏱️ Dosage and Administration ▾
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.
⛔ Contraindications ▾
CONTRAINDICATIONS Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
🤒 Adverse Reactions ▾
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
🤰 Pregnancy ▾
PREGNANCY Pregnancy Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids.
Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.
🧒 Pediatric Use ▾
PEDIATRIC USE Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation.
Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.
🆘 Overdosage ▾
OVERDOSAGE Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects(See PRECAUTIONS ).
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids.
There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man. Pharmacokinetics The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. A significantly greater amount of fluocinonide is absorbed from the solution than from the cream or gel formulations.
Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids.
Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (See DOSAGE AND ADMINISTRATION ). Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees.
Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Fluocinonide Topical Solution USP, 0.05% is supplied in 20 mL (NDC 33342-320-84) and 60 mL(NDC 33342-320-85) bottles. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Avoid excessive heat, above 40°C (104°F).
Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540 Manufacturer Macleods Pharmaceuticals Limited At Oxalis Labs Baddi, Himachal Pradesh, INDIA Revised: December 2022
📋 Description ▾
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. fluocinonide
💬 Information for Patients ▾
INFORMATION FOR THE PATIENTS Patients using topical corticosteroids should receive the following information and instructions: 1. This medication is to be used as directed by the physician. It is for external use only.
Avoid contact with the eyes. If there is contact with the eyes and severe irritation occurs, immediately flush with a large volume of water. 2.
Patients should be advised not to use this medication for any disorder other than for which it was prescribed. 3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.
4. Patients should report any signs of local adverse reactions especially under occlusive dressing. 5.
Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.
💬 Medication Guide ▾
SPL MEDGUIDE