Onychomycosis (fungal infection of the nail) is common, stubborn, and surrounded by more marketing than most conditions its size deserves. Three things are worth knowing before you spend money on treating it: a substantial share of abnormal-looking nails are not fungal at all, the treatments that work best are oral and FDA-approved, and everything in this area takes far longer than people expect.
This guide covers how the diagnosis is confirmed, what each treatment achieves in trials, where compounded preparations fit, and what the timelines really are.
First: confirm it is actually fungus
This is the step most often skipped, and skipping it is how people spend a year treating the wrong thing.
A thickened, discolored, crumbling nail can be fungal. It can also be nail psoriasis, chronic trauma from footwear or running, lichen planus, a bacterial infection, or the aftermath of an old injury. Studies of nails clinically diagnosed as onychomycosis routinely find that a large fraction, often around half, test negative for fungus. Dermatology guidelines recommend mycological confirmation before starting systemic treatment, and the reason is practical: oral antifungals carry real monitoring requirements and drug interactions, and taking them for months for a non-fungal nail is all risk and no benefit.
Confirmation is simple: a KOH preparation, a fungal culture, or PAS staining of a nail clipping. Culture is slower but identifies the organism, which matters because dermatophytes, non-dermatophyte moulds, and Candida do not respond identically.
One thing that should never be assumed to be fungus: a single dark or pigmented streak running the length of one nail, particularly with pigment extending onto the surrounding skin. That pattern needs evaluation for subungual melanoma. It is uncommon, and it is missed often enough that it is worth naming.
How the infection develops
Onychomycosis is caused by fungi, most often dermatophytes such as Trichophyton rubrum, less often moulds or yeasts. They enter through a break in the seal between the nail plate and the nail bed, usually after minor trauma, and colonize the keratin of the plate itself.
Risk rises with age, with diabetes, with peripheral vascular disease, with immunosuppression, with communal barefoot environments, and with occlusive footwear. It very frequently coexists with athlete's foot: tinea pedis on the skin is a reservoir that will reinfect a treated nail, which is why treating the skin alongside the nail matters.
Why nails are hard to treat
Two obstacles, both physical.
The first is the nail plate. It is dense, compacted keratin with no blood supply, built to be a barrier. Most topical drugs simply do not get through it in useful concentrations, which is why topical cure rates in trials are so much lower than oral ones.
The second is growth rate. Infected nail is not repaired: it has to grow out and be replaced. Fingernails advance roughly 3 mm a month and take about four to six months to replace completely. Toenails advance roughly 1 mm a month and take twelve to eighteen months.
That second fact governs everything else. A treatment that works perfectly still leaves a visibly abnormal toenail for a year, because the damaged nail already grown has to reach the end of the toe before it can be cut off. Any claim that a nail cleared in a few months is describing something other than a fully replaced toenail.
Oral antifungals
These are the most effective treatments available for onychomycosis, and any account that says otherwise is not describing the evidence.
Terbinafine is generally considered first-line for dermatophyte infections. A typical regimen is 250 mg once daily for six weeks for fingernails or twelve weeks for toenails. In trials it produces mycological cure in roughly 70–75% of patients and complete cure (clear nail plus negative mycology) in something under 40%. Prescribers commonly check liver function before or during treatment; rare hepatotoxicity is the reason. Taste and smell disturbance can occur and occasionally persists.
Itraconazole is an alternative, given either continuously or in pulses of one week per month. It covers a broader range of organisms, including some moulds and yeasts, but cure rates are generally lower than terbinafine's for dermatophytes. It is a potent CYP3A4 inhibitor with a long list of clinically important drug interactions, and it carries warnings regarding heart failure. The interaction list is the practical constraint: anyone on a statin, certain sedatives, or a range of cardiac medications needs that checked before starting.
Neither drug is casual, and neither is unreasonable. The judgment is a real one made with a prescriber who knows your medication list, not a reason to avoid the category on principle.
FDA-approved topical treatments
Three prescription topicals are approved in the United States for onychomycosis: ciclopirox 8% nail lacquer, efinaconazole 10% solution, and tavaborole 5% solution. They avoid systemic exposure entirely, which makes them attractive for people who cannot or would rather not take an oral antifungal, for mild disease, and for children.
Their trial results are modest. Complete cure rates run from low single digits for ciclopirox lacquer to roughly 15–18% for efinaconazole. Those figures are low partly because "complete cure" is a strict endpoint (a completely normal-looking nail plus negative mycology), and improvement short of that is common. But they are the honest numbers, and they are the reason topical-only treatment is usually reserved for milder cases or combined with other measures.
All three require daily application for 48 weeks. Adherence over that period is itself a significant variable.
Where compounding fits
Compounded nail preparations are not FDA-approved. The FDA has not evaluated them for safety, for effectiveness, or for manufacturing quality, and there are no trials comparing them against the approved topicals above. What follows is a description of what prescribers are attempting when they order one, not a claim that it works better.
The problems compounding is used to address here are specific, and they follow the same pattern set out in our overview of dermatology compounding:
- Penetration. Solvents such as DMSO are included to carry an antifungal through the keratin barrier, which is the central obstacle described above.
- Softening the plate. Urea at keratolytic concentrations thins and softens nail, both to improve penetration and to assist debridement.
- Combining agents. Putting more than one antifungal, or an antifungal with a keratolytic and a solvent, into a single application, chiefly a question of adherence over a year of daily use.
- Oral therapy is not an option. Where an interaction, a liver concern, or patient preference rules out terbinafine and itraconazole, a topical route may be the only route.
- Excipient sensitivity. Building the same drug into a base that omits a specific ingredient the patient reacts to.
Preparations Bayview compounds for this indication combine agents along these lines, for example itraconazole with terbinafine, urea and DMSO in a nail suspension, or itraconazole in a DMSO-based nail solution. Ciclopirox is also compounded in a range of strengths and vehicles, including a ciclopirox olamine cream for the skin around the nail.
One regulatory point belongs here. Section 503A of the Federal Food, Drug, and Cosmetic Act does not permit compounding a preparation that is essentially a copy of a commercially available drug product. Since approved ciclopirox, efinaconazole and tavaborole products exist, a compounded nail preparation needs a reason specific to the patient (a different strength, an added keratolytic, an omitted excipient, an agent not available topically), and that reason belongs on the prescription.
Some ingredients that appear in compounded nail formulas have thin or no supporting evidence for this use: topical biotin and tea tree oil among them. Their presence is not a reason to avoid a preparation, but it is not a reason to choose one either.
What the numbers look like side by side
| Treatment | Route | Typical course | Complete cure |
|---|---|---|---|
| Terbinafine | Oral | 12 weeks (toenail) | Under 40%; mycological cure ~70–75% |
| Itraconazole | Oral | 12 weeks continuous, or 3 monthly pulses | Lower than terbinafine for dermatophytes |
| Efinaconazole 10% | Topical | 48 weeks daily | Roughly 15–18% |
| Tavaborole 5% | Topical | 48 weeks daily | Under 10% |
| Ciclopirox 8% lacquer | Topical | 48 weeks daily | Low single digits |
| Compounded preparations | Topical | Varies | Not established, no comparative trial data |
Read that table as a comparison of strict endpoints, not as a verdict on whether a treatment is worth trying. Partial improvement is far more common than complete cure across every row.
Recurrence, and what actually reduces it
Relapse and reinfection are common, reported across studies somewhere between a fifth and half of patients within a few years of successful treatment. The infection is not gone from the environment just because it is gone from the nail.
Measures that address the reservoir rather than the nail:
- Treat tinea pedis on the surrounding skin at the same time, and keep treating it afterwards.
- Dry thoroughly between the toes; fungi need moisture.
- Rotate shoes so each pair dries fully, and consider antifungal powder or a shoe disinfectant.
- Wear footwear in communal showers, locker rooms, and pool decks.
- Do not share clippers or files, and disinfect your own.
- Keep nails trimmed short and, where the nail is thick, ask about debridement: thinning the plate mechanically improves how much topical drug gets through.
When to see a clinician rather than self-treat
Some situations warrant a professional assessment before anything is applied:
- Diabetes, peripheral neuropathy, or peripheral vascular disease. A minor nail or skin break can become a serious foot infection or ulcer. Self-directed trimming and over-the-counter products are not appropriate here.
- Immunosuppression, from disease or medication.
- A single dark streak or pigment spreading onto the skin around the nail, as above.
- Pain, spreading redness, swelling, or drainage, which suggest bacterial infection rather than a fungal one.
- Only one nail affected with no athlete's foot anywhere, less typical of onychomycosis and worth confirming.
Questions people ask
How long before my nail looks normal?
For a toenail, twelve to eighteen months from the point treatment starts working, because the damaged nail has to grow out. Fingernails are four to six months. Nothing shortens this; it is the growth rate of the nail.
Is a compounded nail preparation better than the prescription topicals?
That has not been established. There are no trials comparing compounded preparations against the approved topicals. Compounding is used to address specific problems (penetration, combining agents, avoiding an excipient, working around a contraindication to oral therapy), not on the basis of demonstrated superiority.
Are oral antifungals dangerous?
They require attention, not avoidance. Terbinafine's rare hepatotoxicity is why liver function is commonly checked; itraconazole's drug interactions are the main practical constraint on its use. Both are widely used, and they are the most effective treatments available. Whether the trade-off makes sense is a conversation with a prescriber who has your medication list, not a decision to make from an article.
Do over-the-counter products work?
Over-the-counter topicals are generally not effective for established nail infection, because they do not penetrate the plate. They can be useful for tinea pedis on the surrounding skin, which is worth treating in its own right.
Do I really need a test first?
Before oral treatment, yes: guidelines recommend it, and a large share of nails that look fungal are not. Before a topical, it is still worth doing, because a year of daily application for the wrong diagnosis is a year lost.
Will laser treatment fix it?
Devices in this category have been cleared for temporary increase in clear nail, which is a different and lower bar than curing the infection. Evidence for durable cure is weak. It is not a substitute for antifungal therapy.
Can I get a compounded nail treatment without a prescription?
No. Compounded preparations are prescription medications, made for a named patient on a prescriber's order, which is where looking for a compounding pharmacy near you starts.
Will insurance cover a compounded nail preparation?
Usually not. Compounded preparations are frequently excluded from pharmacy benefits. Ask for the cash price up front, and see our cost and ordering questions for what to expect.
Why did it come back?
Most often reinfection rather than treatment failure, from untreated athlete's foot, from shoes, or from a communal environment. The prevention section above is about the reservoir, and it matters as much as the treatment did.
Should I keep painting my nails during treatment?
Ask your prescriber. Polish interferes with some topical products and hides what is happening underneath, which makes it harder to tell whether treatment is working.
Getting started
Start with a clinician who can confirm the diagnosis: a podiatrist, dermatologist, or your primary care provider. Bring a history of what you have already tried and for how long, and your current medication list, since that list is what determines whether an oral antifungal is simple or complicated.
Bayview Pharmacy compounds nail preparations to a prescriber's order, compounded ciclopirox in nail and skin vehicles among them.
Our pharmacists are available to discuss strength, vehicle, and penetration-enhancer questions with you or with your prescriber, the same questions that come up with compounded minoxidil solutions applied to the scalp.
Nail and skin preparations sit alongside the rest of the searchable catalog of compounded medications.
More on our podiatry services and dermatology and skin pages.
This article is for general information and is not medical advice. Compounded preparations are not FDA-approved. Discuss your own situation with a licensed healthcare provider.
Frequently asked questions
What is compounded ciclopirox?
Ciclopirox is a broad-spectrum antifungal used on the skin for athlete's foot, jock itch, ringworm, yeast rashes, and tinea versicolor, on the scalp for seborrheic dermatitis, and on the nails for fungal infection. Manufactured ciclopirox comes as a 0.77% cream, gel, and lotion, a 1% shampoo, and an 8% nail lacquer. Bayview compounds it when your prescriber wants a higher strength, such as a 6% cream or gel, a 1.5% shampoo or solution, or a nail lacquer in a different vehicle. The compounded preparations are not FDA-approved and are prepared to your prescriber's order.
Why compound it when the tubes and lacquer are manufactured?
The manufactured products are one strength in each form. A prescriber may want a 6% cream or gel for a stubborn or widespread skin infection, a 1.5% shampoo, a solution for the feet and the skin around the nails, a lacquer in a vehicle the manufactured one does not offer, or a size the tubes do not come in. A higher strength is not known to work better or faster; it is your prescriber's call. When a manufactured product fits the order, Bayview dispenses the manufactured product.
Will the nail lacquer cure my nail fungus?
Probably not completely, and it is better to know that up front. In the trials of the manufactured 8% lacquer, used every day for 48 weeks with monthly nail trimming, 5.5% to 8.5% of patients ended with a completely clear, fungus-free nail, and about a third had a negative fungal test even though the nail still looked abnormal. Oral terbinafine does better, clearing the nail completely in roughly four in ten people, and fungus returns in a large share of people after any treatment. The compounded lacquer has not been tested in a trial. Topical treatment makes sense for mild disease or when a tablet is not an option, and your prescriber should confirm the fungus with a test first, because at least half of abnormal toenails are not fungal.
How do I use the nail lacquer?
Once a day, usually at bedtime, brush it over the whole nail, the skin at its edge, and under the tip, on top of yesterday's coat, and let it dry. Do not bathe, shower, or swim for 8 hours afterward, and do not wear nail polish over it. Every 7 days wipe all the coats off with rubbing alcohol and start again. Have loose or thickened infected nail trimmed by your prescriber or a foot specialist about once a month; if you have diabetes or poor circulation, do not trim it yourself. Keep the lacquer away from heat and flame. Expect a course of up to 48 weeks.
How do I use the cream, gel, or shampoo?
Cream or gel: massage a thin layer into the affected skin and the skin around it twice a day, morning and evening, and wash your hands afterward; do not cover the area unless told to. You should see improvement within a week or two; if there is none after 4 weeks, tell your prescriber. Shampoo: wet the hair, work about a teaspoon into the scalp, leave it for 3 minutes, and rinse; the usual schedule is twice a week for 4 weeks with at least 3 days between washes. Keep every form out of the eyes, mouth, and vagina.
What are the side effects, and who should not use it?
Ciclopirox is well tolerated. The usual effects are redness, burning, stinging, or itching where it is applied; the lacquer can redden the skin around the nail and, less often, discolor or reshape the nail; the shampoo can discolor lighter hair. Stop and tell your prescriber if the area blisters, oozes, swells, or the redness spreads. Do not use it if you are allergic to it. Tell your prescriber if you are pregnant or breastfeeding, have diabetes or poor circulation, or have a weakened immune system. The manufactured cream is not established under age 10, the lacquer under 12, and the shampoo under 16.
What is compounded DMSO cream?
A cream or gel made with dimethyl sulfoxide, a solvent that passes through skin and carries other substances with it, prepared by Bayview at 10% (gel) or 50% (cream) to a prescriber's order. No DMSO cream or gel is manufactured; the only FDA-approved DMSO product is a bladder solution for interstitial cystitis. Compounded topical DMSO is not FDA-approved, its use is off-label, and a prescription is required.
What do prescribers use it for?
Most often for pain and inflammation in one place: an arthritic knee or hand, a sprain, tendinitis, or bursitis. Some prescribers also use it as a base that helps another ingredient in a custom cream reach deeper tissue. The trials of DMSO alone in knee osteoarthritis are old and of limited quality, so it is a case-by-case decision for your prescriber, not a proven treatment.
What are the side effects?
Besides the garlic-like taste and odor, the common effects are on the skin where it is applied: dryness, redness, itching, warmth, or burning. Blisters or a rash can develop, especially with the 50% cream or under a bandage. Lens changes were seen in animals given high doses, so tell your prescriber about any change in vision. Get medical care for hives, swelling, wheezing, or faintness.
How much do compounded medications cost?
Pricing varies depending on ingredients and formulation complexity.
Do you accept insurance?
Most compounded medications are not covered by insurance. We can always try and run your insurance prior to compounding your prescription if you wish.
Do I need a prescription?
Yes. All of our medications require a valid prescription from a licensed provider. We're a dispensing and compounding pharmacy, so we don't provide consultations or write prescriptions. If you don't have one yet, you'll need to see a provider first.
How do providers send a prescription to Bayview?
Providers can submit a prescription three ways:
- E-prescribe: Search Bayview Pharmacy, Warwick, RI (NCPDP 4106882) in your EHR. For compounds, use the compound, custom, or free-text option and include the full formulation, strength, quantity, refills, and directions.
- Fax: Send a signed order to 401-284-4506 (alt. 401-210-2757) with patient and prescriber details, medication, quantity, refills, directions, signature, and date.
- Phone: Call 401-284-4505 to submit, clarify, or coordinate refills.
A valid prescription is required, and compounded medications are not FDA-approved.
What Bayview compounds for this
Important: Compounded medications are prepared to a prescriber's order for an individual patient. They are not FDA-approved, and the FDA has not evaluated them for safety, effectiveness, or manufacturing quality. This article is educational and is not a substitute for advice from your prescriber or pharmacist.
This preparation contains a controlled substance. Controlled-substance prescriptions carry refill limits, must be e-prescribed, and can only be shipped to states where Bayview holds the required licensure.
Uses discussed here may be off-label, meaning they are not part of any FDA-approved labeling. Off-label use is a decision for you and your prescriber, based on the available evidence.
Veterinary preparations are compounded to a veterinarian's order for a specific animal and are not FDA-approved animal drugs. Never give a compounded human medication to an animal without veterinary direction.
Compounded prescriptions are paid for directly rather than billed through insurance. Most are HSA/FSA-eligible, and many patients submit the receipt to their plan for possible reimbursement. Pricing depends on the strength, dose form and quantity your prescriber orders. Read more about cost and insurance.
Compounded ciclopirox preparations start at $145, with the final price set by the strength, vehicle, and quantity your prescriber orders. Compounded preparations are generally not billed through insurance, because they do not carry the national drug codes that pharmacy benefit plans process, so most patients pay a cash price. Ask for that price before the prescription is filled.
Bayview Pharmacy is a compounding pharmacy in Warwick, Rhode Island, licensed to fill and ship compounded prescriptions for patients in Rhode Island, Massachusetts, Connecticut, New Jersey, New Hampshire, Florida, Maine and Pennsylvania. Prescriptions for New York patients are filled on a limited basis, and controlled substances are not shipped to New York addresses. See every state we ship to.
Related reading
