FDA-filed SPL labeling · retrieved through openFDA

Ciclopirox Topical

Ciclopirox topical is an antifungal medication used to treat fungal nail infections (onychomycosis) and related skin conditions.

Brand names Penlac Nail LacquerCiclodanLoproxCiclopirox Olamine
Drug classes Decreased Dna Replication
Rx Forms 3 Route Topical
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 43 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveApr 30, 2020
Clinical labels in scope 43
AvailabilityRx
Earliest approval/marketing year 1982
FDA-listed product records 99
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 22, 2026
Ciclopirox Topical at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Ciclopirox topical is an antifungal used to treat fungal nail infections and fungal skin conditions, depending on the specific product and formulation prescribed. The nail lacquer (Ciclodan) works best as part of a full treatment plan that includes professional nail removal and regular trimming. Use it for the full recommended time, watch the treated area for signs of irritation, and check with your doctor or pharmacist if anything seems off.

📖 Ciclopirox Topical: Patient Information Guide

A plain-language walkthrough of Ciclopirox Topical — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Ciclopirox topical is an antifungal medicine available in several forms, each approved for specific uses.

  • Ciclodan (topical solution, 8% nail lacquer): Treats mild to moderate onychomycosis (fungal nail infection) of the fingernails or toenails caused by Trichophyton rubrum, in adults with healthy immune systems, when the infection does not involve the lunula (white crescent at the nail base). Used as part of a comprehensive management program including professional nail care.
  • Ciclopirox Olamine and Loprox (topical suspension): Used to treat fungal skin infections applied to the affected skin.
  • Ciclopirox Olamine and Loprox (topical cream, ointment, or gel): Used to treat fungal skin infections applied to the affected skin area.
⚙️How it works

Ciclopirox is believed to fight fungal infections by latching onto metal ions — particularly iron (Fe³⁺) and aluminum (Al³⁺) — inside the fungal cell. By grabbing onto these metals, it blocks enzymes the fungus depends on to neutralize harmful byproducts called peroxides. Without these enzymes working properly, the fungal cell cannot survive. Researchers consider this the most likely explanation, though its full clinical significance is still being studied.

Laboratory testing shows ciclopirox is active against Trichophyton rubrum and Trichophyton mentagrophytes, two common dermatophytic molds (fungi that infect skin and nails). However, standardized resistance testing methods for these organisms have not yet been established, and cross-resistance studies with other antifungals have not been performed.

💊How it's taken

The right way to use ciclopirox depends on which product and form you have been prescribed — do not assume instructions from one form apply to another.

  • Ciclodan (topical solution, 8% nail lacquer): Applied once daily, ideally at bedtime or at least 8 hours before washing, to all affected nails with the brush provided. A new coat is layered over the previous one daily; the entire buildup is removed with alcohol once every 7 days. This cycle continues for the full course of treatment (up to 48 weeks).
  • Ciclopirox Olamine / Loprox suspension, cream, ointment, or gel: Applied to the affected skin area as directed by your prescriber. Use for the full treatment period even if symptoms improve.

Always follow the instructions on your specific product label and from your prescriber or pharmacist.

🤒Side effects — in detail

Most side effects from ciclopirox topical products occur at or near the treated area and are generally mild.

  • Redness around the nail or nail fold (periungual erythema)
  • Irritation or burning at the application site
  • Nail shape changes, discoloration, or ingrown toenail
  • Mild rash near the treated area
  • Skin irritation, itching, or increased redness with the suspension or cream/gel forms

Stop using the product and contact your doctor right away if you notice significant worsening of redness, blistering, swelling, oozing, or any sign of an allergic reaction — these may mean you are having a sensitivity reaction that needs medical attention.

⚠️Warnings & precautions
  • Sensitivity reactions: If your skin becomes more irritated, red, blistered, swollen, or starts to ooze after applying ciclopirox, stop treatment and call your doctor. This may indicate a chemical or allergic reaction.
  • Not for eye use: Ciclopirox topical suspension is not intended for use in or near the eyes.
  • Do not use occlusive dressings: Avoid covering the treated area with tight, airtight bandages or wrappings unless your doctor specifically instructs you to.
  • Diabetes and nail care: People with diabetes need to discuss nail care procedures carefully with their health care professional before starting treatment with Ciclodan nail lacquer, as nail trimming and removal carry extra risk.
  • Duration of therapy: Safety and effectiveness of Ciclodan beyond 48 weeks have not been established. Do not extend treatment without medical guidance.
  • Use under supervision: Ciclodan nail lacquer should be used only under medical supervision as part of a managed nail treatment program.
🔀What it interacts with

There is one key drug interaction to be aware of with ciclopirox topical products.

  • Systemic (oral) antifungal medications for nail infections: Do not use Ciclodan (ciclopirox topical solution, 8%) at the same time as an oral antifungal drug taken for onychomycosis. It is not known whether ciclopirox might reduce how well those oral medications work, so this combination is not recommended.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Allergy to any ingredient: Ciclodan nail lacquer is contraindicated (must not be used) if you have had a hypersensitivity reaction to any of its components.
  • Pregnancy: Ciclopirox topical suspension is Pregnancy Category B — animal studies showed no harm, but there are no well-controlled studies in pregnant women. Use only if the benefit clearly outweighs the risk. The nail lacquer has not been studied in pregnant or nursing women at all.
  • Breastfeeding: It is not known whether ciclopirox passes into breast milk. Use ciclopirox suspension with caution and discuss with your doctor if you are nursing.
  • Weakened immune system: Ciclodan nail lacquer has not been studied in people with HIV, a history of immune suppression, or organ transplant recipients. Tell your doctor about your immune health before starting.
  • Diabetes or diabetic neuropathy: Special nail care precautions apply. Discuss the full treatment plan with your doctor before starting Ciclodan.
  • Epilepsy medications: People who require medication to control epilepsy were excluded from Ciclodan clinical trials. Let your doctor know if you take these medications.
  • Children: Safety and effectiveness of ciclopirox topical suspension have not been established in children under 10 years old.
🔬Pharmacokinetics — how your body processes it

When ciclopirox is taken by mouth, it is rapidly absorbed and almost completely eliminated from the body through urine and feces, mostly as glucuronide (a processed, water-soluble form). About 96% of an oral dose is excreted in the urine within 12 hours, with 94% of that in the glucuronide form — meaning the liver processes most of it before it leaves the body.

When Ciclodan (8% nail lacquer) is applied to all 20 nails daily for six months, small amounts are absorbed through the nail into the bloodstream — blood levels ranged from 12 to 80 ng/mL in a small study. The amount absorbed from the nail lacquer form is low compared to oral dosing, but some systemic exposure does occur with extended use.

📦How to store it

Protect from light (e. store the bottle in the carton after every use). stored at room temperature between 59° and 86° F (15° and 30° C).

📄 Written from Ciclopirox Topical’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Ciclopirox Topical — the kind of thing our pharmacy team would talk through with you at the counter.

How long does it take for the nail lacquer to work?
Fungal nail infections are slow to clear, and Ciclodan nail lacquer is no exception. In clinical studies, treatment lasted up to 48 weeks. Only a small percentage of patients achieved a completely clear nail by the end of treatment, so patience is key. Keep using it as directed even if you don't see dramatic improvement early on, and check in with your doctor if there is no change after several weeks.
Do I need to remove the nail lacquer every night before I apply a new coat?
No — that's actually one of the most important things to get right. You apply Ciclodan once a day and leave it on. Each new coat goes right on top of the previous one. After seven days, you remove all the buildup with alcohol, file away any loose nail material, then start the cycle again. Don't try to remove it daily — that's not how it's meant to work.
Can I use this along with an antifungal pill my doctor prescribed?
That combination is not recommended for the nail lacquer. It's not clear whether Ciclodan might interfere with how well oral antifungal medications work, so the two should not be used together for nail infections. If your doctor is considering both treatments, make sure they know you're using the nail lacquer and discuss it with them directly.
What side effects should I expect, and what should make me call my doctor?
The most common side effects are mild — redness or irritation around the nail, minor skin changes near the nail fold, or slight discoloration. Those are generally okay to continue with. What you should call your doctor about is any significant worsening: blistering, swelling, oozing, or a spreading rash. Those could be signs of a sensitivity reaction and need prompt attention.
Is it safe to use this if I have diabetes?
You can potentially use it, but diabetes requires extra caution — especially around nail care. Trimming and removing infected nail tissue carries higher risk if you have diabetic nerve damage or poor circulation. Your health care team needs to be closely involved in managing your nails throughout the treatment. Make sure your doctor knows about your diabetes before you start.
Can I use ciclopirox cream or suspension on my face or near my eyes?
The topical suspension is specifically not for use in or near the eyes — keep it away from that area. For any use on your face or sensitive areas, follow your prescriber's specific instructions. If the product accidentally gets in your eyes, rinse thoroughly and contact your doctor or pharmacist.
Is Ciclopirox Topical available over the counter?
Ciclopirox Topical is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Ciclopirox Topical first available?
Ciclopirox Topical has been available in the United States since at least 1982, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Ciclopirox Topical?
Ciclopirox Topical is supplied by 23 manufacturers listed in the FDA NDC Directory, including Bryant Ranch Prepack, Padagis Israel Pharmaceuticals Ltd, Glenmark Pharmaceuticals Inc., USA.

💬 Answers drafted from Ciclopirox Topical’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Ciclopirox Topical comes

Ciclopirox Topical is available in 3 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Topical cream, ointment or gel

On the skin
Brands Ciclopirox Olamine Loprox
How this form is used
What it may be used for
  • Ciclopirox Olamine and Loprox cream, ointment, or gel are used to treat fungal skin infections applied topically to the affected area
Important instructions
  • Apply Ciclopirox Olamine or Loprox cream, ointment, or gel to the affected skin as directed by your prescriber
  • Use for the full prescribed treatment period even if your skin looks better, and contact your doctor if there is no improvement after four weeks
  • Do not cover the treated area with tight, occlusive bandages or wrappings
Available strengths 3 strengths
53 FDA-listed product records

Topical solution

On the skin
Brands Ciclodan
How this form is used
What it may be used for
  • Ciclodan is used to treat mild to moderate onychomycosis (fungal nail infection) of the fingernails or toenails caused by Trichophyton rubrum, in adults with healthy immune systems whose infection does not reach the lunula (base of the nail)
Important instructions
  • Ciclodan should be applied once daily, preferably at bedtime or at least 8 hours before washing, to all affected nails using the applicator brush provided
  • Ciclodan should be applied evenly over the entire nail plate and, where possible, to the nail bed and underside of the nail
  • Do not remove Ciclodan daily — apply a fresh coat over the previous one each day, and remove the buildup with alcohol every 7 days
  • Ciclodan is used as part of a comprehensive program that includes monthly professional removal of unattached infected nail and weekly patient trimming with an emery board
Available strengths 3 strengths
29 FDA-listed product records

Topical suspension

On the skin
Brands Ciclopirox Olamine Loprox
How this form is used
What it may be used for
  • Ciclopirox Olamine and Loprox topical suspension are used to treat fungal skin infections applied to the affected skin area
Important instructions
  • Ciclopirox Olamine and Loprox topical suspension are for skin use only — do not use in or near the eyes
  • Use for the full treatment period even if symptoms improve, and notify your doctor if there is no improvement after four weeks
  • Do not cover the treated area with occlusive bandages or wrappings
Available strengths 2 strengths
17 FDA-listed product records

📊 Ciclopirox Topical across the U.S. market

How Ciclopirox Topical appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

3
Dose forms
23
Manufacturers
4
Brand names
99
FDA-listed product records
1982
First marketed

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Bryant Ranch Prepack41%
Padagis Israel Pharmaceuticals Ltd14%
Glenmark Pharmaceuticals Inc., USA5%
Taro Pharmaceuticals U.S.A., Inc.4%
NuCare Pharmaceuticals,Inc.4%
Acella Pharmaceuticals, LLC3%
Other makers28%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Ciclopirox Topical is used

A general measure of how commonly Ciclopirox Topical is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Ciclopirox Topical is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

437,507
Medicaid prescriptions filled (Q1–Q4 2025)
$10.2M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Ciclopirox Topical prescribed? Of the 1,596 medications we measure, Ciclopirox Topical ranks #279 by Medicaid prescriptions — more than 83% of them.

Where Ciclopirox Topical ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Ciclopirox Topical product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 80 mg/mL topical solution is the most-dispensed Ciclopirox Topical product — about 61% of these Medicaid prescriptions.

ciclopirox 80 MG/ML Topical Solution Most dispensed

264,995 Medicaid prescriptions (Q1–Q4 2025) 61% of Ciclopirox Topical prescriptions shown $5.5M gross reimbursement (before rebates) ≈ $21 per prescription (gross)

Summed across the 5 of 16 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 309291

ciclopirox 7.7 MG/ML Topical Cream

102,240 Medicaid prescriptions (Q1–Q4 2025) 23% of Ciclopirox Topical prescriptions shown $1.7M gross reimbursement (before rebates) ≈ $16 per prescription (gross)

Summed across the 12 of 23 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 309289

ciclopirox 10 MG/ML Medicated Shampoo

54,240 Medicaid prescriptions (Q1–Q4 2025) 12% of Ciclopirox Topical prescriptions shown $2.1M gross reimbursement (before rebates) ≈ $38 per prescription (gross)

Summed across the 3 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 250344

ciclopirox 7.7 MG/ML Topical Lotion

12,069 Medicaid prescriptions (Q1–Q4 2025) 3% of Ciclopirox Topical prescriptions shown $726,079 gross reimbursement (before rebates) ≈ $60 per prescription (gross)

Summed across the 2 of 14 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 309290

ciclopirox 0.0077 MG/MG Topical Gel

3,963 Medicaid prescriptions (Q1–Q4 2025) <1% of Ciclopirox Topical prescriptions shown $222,598 gross reimbursement (before rebates) ≈ $56 per prescription (gross)

Summed across the 6 of 19 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313941

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Ciclopirox Topical, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 28 of 77 listed Ciclopirox Topical NDCs with Medicaid activity.

🔍 Compare Ciclopirox Topical products

A representative set of FDA-listed product records for Ciclopirox Topical — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 99 of 99 products — FDA National Drug Code Directory. See every product, package size and price: browse all 99 Ciclopirox Topical NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Ciclopirox Topical RxCUI 21090 5 dose forms · 5 strengths
  1. Dose form (SCDF) Medicated Shampoo RxCUI 379154 In current FDA listings
    Clinical drug / strength (SCD) 10 MG/ML RxCUI 250344
  2. Dose form (SCDF) Topical Cream RxCUI 377873 In current FDA listings
    Clinical drug / strength (SCD) 7.7 MG/ML RxCUI 309289
  3. Dose form (SCDF) Topical Gel RxCUI 378069 In current FDA listings
    Clinical drug / strength (SCD) 0.0077 MG/MG RxCUI 313941
  4. Dose form (SCDF) Topical Lotion RxCUI 377874 In current FDA listings
    Clinical drug / strength (SCD) 7.7 MG/ML RxCUI 309290
  5. Dose form (SCDF) Topical Solution RxCUI 371504 In current FDA listings
    Clinical drug / strength (SCD) 80 MG/ML RxCUI 309291

Look up RxCUI 21090 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Penlac Nail Lacquer Ciclodan Loprox Ciclopirox Olamine

🏭 Manufacturers & labelers

Bryant Ranch Prepack 41 Padagis Israel Pharmaceuticals Ltd 14 Glenmark Pharmaceuticals Inc., USA 5 Taro Pharmaceuticals U.S.A., Inc. 4 NuCare Pharmaceuticals,Inc. 4 Acella Pharmaceuticals, LLC 3 Preferred Pharmaceuticals, Inc. 3 Cosette Pharmaceuticals, Inc. 2 Encube Ethicals, Inc. 2 Medimetriks Pharmaceuticals, Inc. 2 Advanced Rx Pharmacy of Tennessee, LLC 2 Padagis US LLC 2 Actavis Pharma, Inc. 2 RPK Pharmaceuticals, Inc. 2 Sun Pharmaceutical Industries, Inc. 2 A-S Medication Solutions 2 Chartwell RX, LLC 1 Encube Ethicals Private Limited 1 Bausch Health US, LLC 1 Leading Pharma, LLC 1 Akorn 1 Preferred Pharmaceuticals Inc. 1 Teligent Pharma, Inc. 1

RxNorm drug class

Ciclopirox Topical belongs to the Other antifungals for topical use class.

Drug family (ATC) Other antifungals for topical use, Other antiinfectives and antiseptics
How it works Protein Synthesis Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Apr 30, 2020
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Ciclopirox Topical.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Ciclopirox Topical after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
43
NDC products indexed
99
Distinct labelers/manufacturers represented
23
Linked representative label
Leading Pharma, LLC
Linked label effective
Apr 30, 2020
Composite sections available
18
Linked SPL Set ID
370ab878-2753-435f-ae06-67ec9f9502e1
Linked SPL Document ID
232bf664-5638-47a3-a464-440467039140
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 43 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Leading Pharma, LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.