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Ciclopirox 80 mg/mL Solution, 1 bottle — NDC 45802-141-67 (Billing 45802-0141-67)

by Padagis Israel Pharmaceuticals Ltd · 1 BOTTLE, WITH APPLICATOR in 1 CARTON / 6.6 mL in 1 BOTTLE, WITH APPLICATOR

This is a package of 1 bottle of Ciclopirox 80 mg/mL Solution from Padagis Israel Pharmaceuticals Ltd, marketed since Sep 2007 and currently FDA-listed; retail pharmacies pay about $1.15 per mL (NADAC). It is this product's only package size.

NDC 45802-0141-67
🏷️ FDA NDC (as labeled) 45802-141-67 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 45802-141-67
Product NDC 45802-141
11-digit billing NDC 45802014167
NCPDP billing unit ML — per mL (volume)
RxCUI 309291
UNII 19W019ZDRJ
Application # ANDA077623
SPL Set ID 02f46b6e-b424-4210-83bf-e79618df4344
Mechanism of action Protein Synthesis Inhibitors
Physiologic effect Decreased DNA Replication; Decreased Protein Synthesis; Decreased RNA Replication
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2007-09-19
Route TOPICAL
Dosage form SOLUTION
Substance CICLOPIROX
TE code (Orange Book) AT · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 90150030002020
GPI class Ciclopirox
GCN Seq No 037020
GCN 08040
HICL code 016915
Ingredient (HICL) Ciclopirox
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5F
Therapeutic class — specific (HIC3) Topical Antifungals
AHFS code 84:04.08.20
AHFS class Hydroxypyridones (Skin, Mucous Membrane)
FDB label name CICLOPIROX 8% SOLUTION
FDB brand name Ciclopirox
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 037020
  • GCN: 08040
  • GPI-14 (Medi-Span): 90150030002020
  • HICL (First Databank): 016915
  • AHFS class code: 84:04.08.20
  • RxCUI (RxNorm): 309291
Why two NDCs? The FDA registers this code as 45802-141-67 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 45802-0141-67. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine 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
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name CICLOPIROX 8% SOLUTION Ingredient Ciclopirox
📗 Our plain-language guide HelloPharmacist
  • It's treating a fungal infection living inside your nail. Ciclodan (the 8% nail lacquer solution) works specifically on onychomycosis — a fungal infection of the nail plate caused...
  • What is this medicine actually treating — my nail or a skin infection?
  • Nail infections are slow to treat because nails grow slowly. Clinical studies used ciclopirox nail lacquer for 48 weeks — that's nearly a year. Even then, complete clearing of the...
  • How long will I have to use this before I see results?
📖 Read our full Ciclopirox Topical guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer mLPer package
Retail pharmacies payNADAC · weekly $1.154 $7.62 / 6.6 ml
Medicaid paysCMS SDUD · 12 mo $2.88 $18.98 / 6.6 ml
Medicare drug plans payPart D · Q2 2026 $3.03 $20.03 / 6.6 ml
NADAC price history (per mL) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $2.044 $1.154
▼ Down 36% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
45802-0141-67 You're viewing this Main listing 1 BOTTLE, WITH APPLICATOR in 1 CARTON / 6.6 mL in 1 BOTTLE, WITH APPLICATOR 2007-09-19 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ciclopirox 80 mg/mL 21922-0053-51 Encube 1 bottle $1.154 AT Availability likely —
Ciclopirox 80 mg/mL 42192-0715-06 Acella 1 bottle $1.154 AT Availability likely —
Ciclopirox 80 mg/mLthis 45802-0141-67 Padagis 1 bottle $1.154 AT Availability likely —
Ciclopirox 42192-0714-01 Acella 1 kit $7.355 — Availability likely +537%
Ciclopirox 80 mg/mL 50090-6562-00 A-S 1 bottle — AT FDA listed —
Ciclopirox 71.3 mg/mL 62135-0814-45 Chartwell 6.6 ml — AT FDA listed —
Ciclopirox 80 mg/mL 63629-8623-01 Bryant 1 bottle — AT FDA listed —
Ciclopirox 80 mg/mL 68788-6797-06 Preferred 1 bottle — AT FDA listed —
Ciclopirox 80 mg/mL 68788-8755-06 Preferred 1 bottle — AT FDA listed —
Ciclopirox 80 mg/mL 71335-2836-01 Bryant 1 bottle — AT FDA listed —
Ciclopirox 80 mg/mL 72162-1321-02 Bryant 1 bottle — AT FDA listed —
Ciclopirox 80 mg/mL 72162-2076-01 Bryant 1 bottle — AT FDA listed —
Ciclopirox 80 mg/mL 72162-2298-02 Bryant 1 bottle — AT FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2007
On the market since
Sep 2007
📍
2026
Currently FDA-listed
19 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerPadagis Israel Pharmaceuticals Ltd
Application holderPADAGIS US LLC
FDA applicationANDA077623 (ANDA)
Labeler code45802
First marketedSep 2007
Product typeHuman Prescription Drug
Portfolio175 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 🔬 Clinical Studies 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~3 min read ▾

INDICATIONS AND USAGE (To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.) Ciclopirox Topical Solution, 8% as a component of a comprehensive management program, is indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum . The comprehensive management program includes removal of the unattached, infected nails as frequently as monthly, by a health care professional who has special competence in the diagnosis and treatment of nail disorders, including minor nail procedures. • No studies have been conducted to determine whether ciclopirox might reduce the effectiveness of systemic antifungal agents for onychomycosis.

Therefore, the concomitant use of 8% ciclopirox topical solution and systemic antifungal agents for onychomycosis, is not recommended. • Ciclopirox Topical Solution, 8% should be used only under medical supervision as described above. • The effectiveness and safety of ciclopirox topical solution, 8% in the following populations has not been studied. The clinical trials with use of ciclopirox topical solution, 8% excluded patients who: were pregnant or nursing, planned to become pregnant, had a history of immunosuppression (e.g., extensive, persistent, or unusual distribution of dermatomycoses, extensive seborrheic dermatitis, recent or recurring herpes zoster, or persistent herpes simplex), were HIV seropositive, received organ transplant, required medication to control epilepsy, were insulin dependent diabetics or had diabetic neuropathy.

Patients with severe plantar (moccasin) tinea pedis were also excluded. • The safety and efficacy of using Ciclopirox Topical Solution, 8% daily for greater than 48 weeks have not been established. Clinical Trials Data - The results of use of ciclopirox topical solution, 8% in treatment of onychomycosis of the toenail without lunula involvement were obtained from two double-blind, placebo-controlled studies conducted in the United States. In these studies, patients with onychomycosis of the great toenails without lunula involvement were treated with ciclopirox topical solution, 8% in conjunction with monthly removal of the unattached, infected toenail by the investigator.

Ciclopirox topical solution, 8%, was applied for 48 weeks. At baseline, patients had 20–65% involvement of the target great toenail plate. Statistical significance was demonstrated in one of two studies for the endpoint "complete cure" (clear nail and negative mycology), and in two studies for the endpoint "almost clear" (≤10% nail involvement and negative mycology) at the end of study.

These results are presented below. At Week 48 (plus Last Observation Carried Forward) for the Intent-to-Treat (ITT) Population Study 312 Study 313 Active Vehicle Active Vehicle Complete Cure* 6/110 (5.5%) 1/109 (0.9%) 10/118 (8.5%) 0/117 (0%) Almost Clear** 7/107 (6.5%) 1/108 (0.9%) 14/116 (12%) 1/115 (0.9%) Negative Mycology Alone*** 30/105 (29%) 12/106 (11%) 41/115 (36%) 10/114 (9%) * Clear nail and negative mycology ** ≤ 10% nail involvement and negative mycology *** Negative KOH and negative culture The summary of reported patient outcomes for the ITT population at 12 weeks following the end of treatment are presented below.

Note that post-treatment efficacy assessments were scheduled only for patients who achieved a complete cure. Post-Treatment Week 12 Data for Patients Who Achieved Complete Cure at Week 48 Study 312 Study 313 Active Vehicle Active Vehicle Number of Treated Patients 112 111 119 118 Complete Cure at Week 48 6 1 10 0 Post-treatment Week 12 Outcomes: Patients Missing All Week 12 Assessments 2 0 2 0 Patients with Week 12 Assessments 4 1 8 0 Complete Cure 3 1 4 0 Almost Clear 2* 1 1* 0 Negative Mycology 3 1 5 0 *Four patients (from studies 312 and 313) who were completely cured did not have post-treatment Week 12 planimetry… [Excerpted — this section continues on DailyMed.]

⏱️ Dosage and Administration ~1 min read ▾

DOSAGE AND ADMINISTRATION Ciclopirox Topical Solution, 8% should be used as a component of a comprehensive management program for onychomycosis. Removal of the unattached, infected nail, as frequently as monthly, by a health care professional, weekly trimming by the patient, and daily application of the medication are all integral parts of this therapy. Careful consideration of the appropriate nail management program should be given to patients with diabetes (see PRECAUTIONS ).

Nail Care By Health Care Professionals - Removal of the unattached, infected nail, as frequently as monthly, trimming of onycholytic nail, and filing of excess horny material should be performed by professionals trained in treatment of nail disorders. Nail Care By Patient – Patients should file away (with emery board) loose nail material and trim nails, as required, or as directed by the health care professional, every seven days after Ciclopirox Topical Solution, 8% is removed with alcohol. Ciclopirox Topical Solution, 8% should be applied once daily (preferably at bedtime or eight hours before washing) to all affected nails with the applicator brush provided.

Ciclopirox Topical Solution, 8% should be applied evenly over the entire nail plate. If possible, Ciclopirox Topical Solution, 8% should be applied to the nail bed, hyponychium, and the under surface of the nail plate when it is free of the nail bed (e.g., onycholysis). Ciclopirox Topical Solution, 8% should not be removed on a daily basis.

Daily applications should be made over the previous coat and removed with alcohol every seven days. This cycle should be repeated throughout the duration of therapy.

⛔ Contraindications 18 words ▾

CONTRAINDICATIONS Ciclopirox Topical Solution, 8% is contraindicated in individuals who have shown hypersensitivity to any of its components.

⚠️ Warnings 24 words ▾

WARNINGS Ciclopirox Topical Solution, 8% is not for ophthalmic, oral, or intravaginal use. It is for use on nails and immediately adjacent skin only.

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS In the vehicle-controlled clinical trials conducted in the United States, 9% (30/327) of patients treated with ciclopirox topical solution, 8%, and 7% (23/328) of patients treated with vehicle reported treatment-emergent adverse events (TEAE) considered by the investigator to be causally related to the test material. The incidence of these adverse events, within each body system, was similar between the treatment groups except for skin and appendages: 8% (27/327) and 4% (14/328) of subjects in the ciclopirox and vehicle groups reported at least one adverse event, respectively.

The most common were rash-related adverse events: periungual erythema and erythema of the proximal nail fold were reported more frequently in patients treated with ciclopirox topical solution, 8%, (5% [16/327]) than in patients treated with vehicle (1% [3/328]). Other TEAEs thought to be causally related included nail disorders such as shape change, irritation, ingrown toenail, and discoloration. The incidence of nail disorders was similar between the treatment groups (2% [6/327] in the ciclopirox topical solution, 8%, group and 2% [7/328] in the vehicle group).

Moreover, application site reactions and/or burning of the skin occurred in 1% of patients treated with ciclopirox topical solution, 8%, (3/327) and vehicle (4/328). A 21-Day Cumulative Irritancy study was conducted under conditions of semi-occlusion. Mild reactions were seen in 46% of patients with the ciclopirox topical solution, 8%, 32% with the vehicle and 2% with the negative control, but all were reactions of mild transient erythema.

There was no evidence of allergic contact sensitization for either the ciclopirox topical solution, 8% or the vehicle base. In a separate study of the photosensitization potential of ciclopirox topical solution, 8% in a maximized test design that included the occluded application of sodium lauryl sulfate, no photoallergic reactions were noted. In four subjects localized allergic contact reactions were observed.

In the vehicle-controlled studies, one patient treated with ciclopirox topical solution, 8% discontinued treatment due to a rash, localized to the palm (causal relation to test material undetermined). Use of ciclopirox topical solution, 8% for 48 additional weeks was evaluated in an open-label extension study conducted in patients previously treated in the vehicle-controlled studies. Three percent (9/281) of subjects treated with ciclopirox topical solution, 8% experienced at least one TEAE that the investigator thought was causally related to the test material.

Mild rash in the form of periungual erythema (1% [2/281]) and nail disorders (1% [4/281]) were the most frequently reported. Four patients discontinued therapy because of TEAEs. Two of the four had events considered to be related to test material: one patient's great toenail "broke away" and another had an elevated creatine phosphokinase level on Day 1 (after 48 weeks of treatment with vehicle in the previous vehicle-controlled study).

🤰 Pregnancy 103 words ▾

Pregnancy: Teratogenic Effects: Pregnancy Category B - Teratology studies in mice, rats, rabbits, and monkeys at oral doses of up to 77, 23, 23, or 38.5 mg, respectively, of ciclopirox as ciclopirox olamine/kg/day (14, 8, 17, and 28 times MRHTD), or in rats and rabbits receiving topical doses of up to 92.4 and 77 mg/kg/day, respectively (33 and 55 times MRHTD), did not indicate any significant fetal malformations. There are no adequate or well-controlled studies of topically applied ciclopirox in pregnant women. Ciclopirox Topical Solution, 8% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 35 words ▾

Pediatric Use - Based on the safety profile in adults, Ciclopirox Topical Solution, 8% is considered safe for use in children 12 years and older. No clinical trials have been conducted in the pediatric population.

🧓 Geriatric Use 45 words ▾

Geriatric Use - Clinical studies of ciclopirox topical solution, 8% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Microbiology Mechanism of Action - The mechanism of action of ciclopirox has been investigated using various in vitro and in vivo infection models. One in vitro study suggested that ciclopirox acts by chelation of polyvalent cations (Fe +3 or Al +3 ) resulting in the inhibition of the metal-dependent enzymes that are responsible for the degradation of peroxides within the fungal cell. The clinical significance of this observation is not known.

Activity in vitro and ex vivo - In vitro methodologies employing various broth or solid media with and without additional nutrients have been utilized to determine ciclopirox minimum inhibitory concentration (MIC) values for the dermatophytic molds. (1-2) As a consequence, a broad range of MIC values, 1-20 ug/mL, were obtained for Trichophyton rubrum and Trichophyton mentagrophytes species. Correlation between in vitro MIC results and clinical outcome has yet to be established for ciclopirox.

One ex vivo study was conducted evaluating 8% ciclopirox against new and established Trichophyton rubrum and Trichophyton mentagrophytes infections in ovine hoof material. (3) After 10 days of treatment the growth of T. rubrum and T. mentagrophytes in the established infection model was very minimally affected. Elimination of the molds from hoof material was not achieved in either the new or established infection models.

Susceptibility testing for Trichophyton rubrum species - In vitro susceptibility testing methods for determining ciclopirox MIC values against the dermatophytic molds, including Trichophyton rubrum species, have not been standardized or validated. Ciclopirox MIC values will vary depending on the susceptibility testing method employed, composition and pH of media and the utilization of nutritional supplements. Breakpoints to determine whether clinical isolates of Trichophyton rubrum are susceptible or resistant to ciclopirox have not been established.

Resistance - Studies have not been conducted to evaluate drug resistance development in T. rubrum species exposed to 8% ciclopirox topical solution. Studies assessing cross-resistance to ciclopirox and other known antifungal agents have not been performed. Antifungal Drug Interactions - No studies have been conducted to determine whether ciclopirox might reduce the effectiveness of systemic antifungal agents for onychomycosis.

Therefore, the concomitant use of 8% ciclopirox topical solution and systemic antifungal agents for onychomycosis is not recommended. Pharmacokinetics - As demonstrated in pharmacokinetic studies in animals and man, ciclopirox olamine is rapidly absorbed after oral administration and completely eliminated in all species via feces and urine. Most of the compound is excreted either unchanged or as glucuronide.

After oral administration of 10 mg of radiolabeled drug (14C-ciclopirox) to healthy volunteers, approximately 96% of the radioactivity was excreted renally within 12 hours of administration. Ninety-four percent of the renally excreted radioactivity was in the form of glucuronides. Thus, glucuronidation is the main metabolic pathway of this compound.

Systemic absorption of ciclopirox was determined in five patients with dermatophytic onychomycoses, after application of ciclopirox topical solution, 8%, to all 20 digits and adjacent 5 mm of skin once daily for six months. Random serum concentrations and 24 hour urinary excretion of ciclopirox were determined at two weeks and at 1, 2, 4 and 6 months after initiation of treatment and four weeks post-treatment. In this study, ciclopirox serum levels ranged from 12-80 ng/mL.

Based on urinary data, mean absorption of ciclopirox from the dosage form was <5% of the applied dose. One month after cessation of treatment, serum and urine levels of ciclopirox were below the limit of detection. In two vehicle-controlled trials, patients applied ciclopirox topical solution, 8%, to all toenails and affected fingernails.

Out of a total of 66 randomly select… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 54 words ▾

HOW SUPPLIED Ciclopirox Topical Solution, 8% is available as follows: 6.6 mL glass bottle with a screw cap fitted with a brush (NDC 45802- 141 -67) Protect from light (store bottle in the carton after every use). Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. CAUTION: Flammable. Keep away from heat and flame.

📦 Storage and Handling 28 words ▾

Protect from light (store bottle in the carton after every use). Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. CAUTION: Flammable. Keep away from heat and flame.

📋 Description 115 words ▾

DESCRIPTION Ciclopirox Topical Solution, 8% contains a synthetic antifungal agent, ciclopirox. It is intended for topical use on fingernails and toenails and immediately adjacent skin. Each gram of Ciclopirox Topical Solution, 8% contains 80 mg ciclopirox in a solution base consisting of butyl ester of poly [vinylmethylether/maleic acid copolymer] in isopropyl alcohol, ethyl acetate, and isopropyl alcohol.

Ethyl acetate and isopropyl alcohol are solvents that vaporize after application. Ciclopirox Topical Solution, 8% is a clear, colorless to slightly yellowish solution. The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone, with the empirical formula C 12 H 17 NO 2 and a molecular weight of 207.27.

The CAS Registry Number is [29342-05-0]. The chemical structure is: Chemical Structure

💬 Information for Patients ~2 min read ▾

Information for Patients Patients should have detailed instructions regarding the use of Ciclopirox Topical Solution, 8% as a component of a comprehensive management program for onychomycosis in order to achieve maximum benefit with the use of this product. The patient should be told to: 1. Use Ciclopirox Topical Solution, 8% as directed by a health care professional.

Avoid contact with the eyes and mucous membranes. Contact with skin other than skin immediately surrounding the treated nail(s) should be avoided. Ciclopirox Topical Solution, 8% is for external use only.

2. Ciclopirox Topical Solution, 8% should be applied evenly over the entire nail plate and 5 mm of surrounding skin. If possible, Ciclopirox Topical Solution, 8% should be applied to the nail bed, hyponychium, and the under surface of the nail plate when it is free of the nail bed (e.g., onycholysis).

Contact with the surrounding skin may produce mild, transient irritation (redness). 3. Removal of the unattached, infected nail, as frequently as monthly, by a health care professional is needed with use of this medication.

Inform a health care professional if they have diabetes or problems with numbness in the toes or fingers for consideration of the appropriate nail management program. 4. Inform a health care professional if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, or oozing).

5. Up to 48 weeks of daily applications with Ciclopirox Topical Solution, 8% and professional removal of the unattached, infected nail, as frequently as monthly, are considered the full treatment needed to achieve a clear or almost clear nail (defined as 10% or less residual nail involvement). 6.

Six months of therapy with professional removal of the unattached, infected nail may be required before initial improvement of symptoms is noticed. 7. A completely clear nail may not be achieved with use of this medication.

In clinical studies less than 12% of patients were able to achieve either a completely clear or almost clear toenail. 8. Do not use the medication for any disorder other than that for which it is prescribed.

9. Do not use nail polish or other nail cosmetic products on the treated nails. 10.

Avoid use near heat or open flame, because product is flammable.

⚠️ Precautions ~3 min read ▾

PRECAUTIONS If a reaction suggesting sensitivity or chemical irritation should occur with the use of Ciclopirox Topical Solution, 8% treatment should be discontinued and appropriate therapy instituted. So far there is no relevant clinical experience with patients with insulin dependent diabetes or who have diabetic neuropathy. The risk of removal of the unattached, infected nail, by the health care professional and trimming by the patient should be carefully considered before prescribing to patients with a history of insulin dependent diabetes mellitus or diabetic neuropathy.

Information for Patients Patients should have detailed instructions regarding the use of Ciclopirox Topical Solution, 8% as a component of a comprehensive management program for onychomycosis in order to achieve maximum benefit with the use of this product. The patient should be told to: 1. Use Ciclopirox Topical Solution, 8% as directed by a health care professional.

Avoid contact with the eyes and mucous membranes. Contact with skin other than skin immediately surrounding the treated nail(s) should be avoided. Ciclopirox Topical Solution, 8% is for external use only.

2. Ciclopirox Topical Solution, 8% should be applied evenly over the entire nail plate and 5 mm of surrounding skin. If possible, Ciclopirox Topical Solution, 8% should be applied to the nail bed, hyponychium, and the under surface of the nail plate when it is free of the nail bed (e.g., onycholysis).

Contact with the surrounding skin may produce mild, transient irritation (redness). 3. Removal of the unattached, infected nail, as frequently as monthly, by a health care professional is needed with use of this medication.

Inform a health care professional if they have diabetes or problems with numbness in the toes or fingers for consideration of the appropriate nail management program. 4. Inform a health care professional if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, or oozing).

5. Up to 48 weeks of daily applications with Ciclopirox Topical Solution, 8% and professional removal of the unattached, infected nail, as frequently as monthly, are considered the full treatment needed to achieve a clear or almost clear nail (defined as 10% or less residual nail involvement). 6.

Six months of therapy with professional removal of the unattached, infected nail may be required before initial improvement of symptoms is noticed. 7. A completely clear nail may not be achieved with use of this medication.

In clinical studies less than 12% of patients were able to achieve either a completely clear or almost clear toenail. 8. Do not use the medication for any disorder other than that for which it is prescribed.

9. Do not use nail polish or other nail cosmetic products on the treated nails. 10.

Avoid use near heat or open flame, because product is flammable. Carcinogenesis, Mutagenesis, Impairment of Fertility - No carcinogenicity study was conducted with ciclopirox topical solution, 8% formulation. A carcinogenicity study of ciclopirox (1% and 5% solutions in polyethylene glycol 400) in female mice dosed topically twice per week for 50 weeks followed by a six-month drug-free observation period prior to necropsy revealed no evidence of tumors at the application sites.

In human systemic tolerability studies following daily application (~340 mg of ciclopirox topical solution, 8%) in subjects with distal subungual onychomycosis, the average maximal serum level of ciclopirox was 31±28 ng/mL after two months of once daily applications. This level was 159 times lower than the lowest toxic dose and 115 times lower than the highest nontoxic dose in rats and dogs fed 7.7 and 23.1 mg ciclopirox (as ciclopirox olamine)/kg/day. The following in vitro genotoxicity tests have been conducted with ciclopirox: evaluation of gene mutation in Ames Salmonella and E. coli assays (negative); chromosome aberration assays in V79 Chinese hamster lung fibroblasts, with… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 38 words ▾

Nursing Mothers - It is not known whether this drug is excreted in human milk. Since many drugs are excreted in human milk, caution should be exercised when Ciclopirox Topical Solution, 8% is administered to a nursing woman.

🔬 Clinical Studies ~2 min read ▾

Clinical Trials Data - The results of use of ciclopirox topical solution, 8% in treatment of onychomycosis of the toenail without lunula involvement were obtained from two double-blind, placebo-controlled studies conducted in the United States. In these studies, patients with onychomycosis of the great toenails without lunula involvement were treated with ciclopirox topical solution, 8% in conjunction with monthly removal of the unattached, infected toenail by the investigator. Ciclopirox topical solution, 8%, was applied for 48 weeks.

At baseline, patients had 20–65% involvement of the target great toenail plate. Statistical significance was demonstrated in one of two studies for the endpoint "complete cure" (clear nail and negative mycology), and in two studies for the endpoint "almost clear" (≤10% nail involvement and negative mycology) at the end of study. These results are presented below.

At Week 48 (plus Last Observation Carried Forward) for the Intent-to-Treat (ITT) Population Study 312 Study 313 Active Vehicle Active Vehicle Complete Cure* 6/110 (5.5%) 1/109 (0.9%) 10/118 (8.5%) 0/117 (0%) Almost Clear** 7/107 (6.5%) 1/108 (0.9%) 14/116 (12%) 1/115 (0.9%) Negative Mycology Alone*** 30/105 (29%) 12/106 (11%) 41/115 (36%) 10/114 (9%) * Clear nail and negative mycology ** ≤ 10% nail involvement and negative mycology *** Negative KOH and negative culture The summary of reported patient outcomes for the ITT population at 12 weeks following the end of treatment are presented below.

Note that post-treatment efficacy assessments were scheduled only for patients who achieved a complete cure. Post-Treatment Week 12 Data for Patients Who Achieved Complete Cure at Week 48 Study 312 Study 313 Active Vehicle Active Vehicle Number of Treated Patients 112 111 119 118 Complete Cure at Week 48 6 1 10 0 Post-treatment Week 12 Outcomes: Patients Missing All Week 12 Assessments 2 0 2 0 Patients with Week 12 Assessments 4 1 8 0 Complete Cure 3 1 4 0 Almost Clear 2* 1 1* 0 Negative Mycology 3 1 5 0 *Four patients (from studies 312 and 313) who were completely cured did not have post-treatment Week 12 planimetry data.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility - No carcinogenicity study was conducted with ciclopirox topical solution, 8% formulation. A carcinogenicity study of ciclopirox (1% and 5% solutions in polyethylene glycol 400) in female mice dosed topically twice per week for 50 weeks followed by a six-month drug-free observation period prior to necropsy revealed no evidence of tumors at the application sites. In human systemic tolerability studies following daily application (~340 mg of ciclopirox topical solution, 8%) in subjects with distal subungual onychomycosis, the average maximal serum level of ciclopirox was 31±28 ng/mL after two months of once daily applications.

This level was 159 times lower than the lowest toxic dose and 115 times lower than the highest nontoxic dose in rats and dogs fed 7.7 and 23.1 mg ciclopirox (as ciclopirox olamine)/kg/day. The following in vitro genotoxicity tests have been conducted with ciclopirox: evaluation of gene mutation in Ames Salmonella and E. coli assays (negative); chromosome aberration assays in V79 Chinese hamster lung fibroblasts, with and without metabolic activation (positive); gene mutation assay in the HGPRT-test with V79 Chinese hamster lung fibroblasts (negative); unscheduled DNA synthesis in human A549 cells (negative); and BALB/c3T3 cell transformation assay (negative).

In an in vivo Chinese hamster bone marrow cytogenetic assay, ciclopirox was negative for chromosome aberrations at 5,000 mg/kg. The following in vitro genotoxicity tests were conducted with ciclopirox topical solution, 8%: Ames Salmonella test (negative); unscheduled DNA synthesis in the rat hepatocytes (negative); cell transformation assay in BALB/c3T3 cell assay (positive). The positive response of the lacquer formulation in the BALB/c3T3 test was attributed to its butyl monoester of poly[methylvinyl ether/maleic acid] resin component (Gantrez® ES-435), which also tested positive in this test.

The cell transformation assay may have been confounded because of the film-forming nature of the resin. Gantrez® ES-435 tested nonmutagenic in both the in vitro mouse lymphoma forward mutation assay with or without activation and unscheduled DNA synthesis assay in rat hepatocytes. Oral reproduction studies in rats at doses up to 3.85 mg ciclopirox (as ciclopirox olamine)/kg/day [equivalent to approximately 1.4 times the potential exposure at the maximum recommended human topical dose (MRHTD)] did not reveal any specific effects on fertility or other reproductive parameters.

MRHTD (mg/m 2 ) is based on the assumption of 100% systemic absorption of 27.12 mg ciclopirox (~340 mg ciclopirox topical solution, 8%) that will cover all the fingernails and toenails including 5 mm proximal and lateral fold area plus onycholysis to a maximal extent of 50%.

📚 References 71 words ▾

References 1. Dittmar W., Lohaus G. 1973.

HOE296, A new antimycotic compound with a broad antimicrobial spectrum. Arzneim-Forsch./ Drug Res. 23:670-674.

2. Niewerth et . al ., 1998. Antimicrobial susceptibility testing of dermatophytes: Comparison of the agar macrodilution and broth microdilution tests.

Chemotherapy. 44:31-35. 3.

Yang et . al . 1997. A new simulation model for studying in vitro topical penetration of antifungal drugs into hard keratin.

J. Mycol. Med.

7:195-98.

📄 Patient Package Insert ~3 min read ▾

Patient Instructions Ciclopirox Topical Solution, 8% Nail Lacquer Rx Only Patient Information and Instructions Patients should have detailed instructions regarding the use of Ciclopirox Topical Solution, 8% as a component of a comprehensive management program for onychomycosis in order to achieve maximum benefit with the use of this product. Discuss your treatment plan with your health care professional for regular removal of the unattached, infected nail. Before using this medication, tell your doctor if you: • Are pregnant or nursing • Are an insulin dependent diabetic or have diabetic neuropathy • Have a history of immunosuppression • Are immunocompromised (e.g., received an organ transplant, etc.) • Require medication to control epilepsy • Use or require topical corticosteroids on a repeated monthly basis • Use steroid inhalers on a regular basis Patient Information: • Use Ciclopirox Topical Solution, 8% as directed by your health care professional. • Ciclopirox Topical Solution, 8% is for external use only. • Contact with skin other than skin immediately surrounding the treated nail(s) should be avoided. • Avoid contact with the eyes and mucous membranes. • Removal of the unattached, infected nail, as frequently as monthly, by your health care professional is needed with use of this medication to obtain maximal benefit with use of this product.

If you have diabetes or problems with numbness in your toes or fingers, talk to your health care provider before trimming your nails or removing any nail material. • Inform your health care professional if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, or oozing). • Up to 48 weeks of daily applications with Ciclopirox Topical Solution, 8% and professional removal, as frequently as monthly, of the unattached, infected nail are considered the full treatment time to achieve a clear or almost clear nail (defined as 10% or less residual nail involvement).

Six months of therapy with professional removal of the unattached, infected nail may be required before initial improvement of symptoms is noticed. • A completely clear nail may not be achieved with use of this medication. In clinical studies less than 12% of patients were able to achieve either a clear or almost clear toenail. • Do not use nail polish or other nail cosmetic products on the treated nails. • Avoid use near heat or open flame, because product is flammable. Patient Instructions 1- Before starting treatment, remove any loose nail or nail material using scissors, nail clippers or a nail file.

If you have diabetes or problems with numbness in your toes or fingers, talk to your health care provider before trimming your nails or removing any nail material. 2- Apply Ciclopirox Topical Solution, 8% once daily (preferably at bed time) to all affected nails with the applicator brush provided. Apply the lacquer evenly over the entire nail.

Where possible, nail lacquer should also be applied to the underside of the nail and to the skin beneath it. Allow lacquer to dry (approximately 30 seconds) before putting on socks or stockings. After applying the medication, wait eight hours before taking a bath or shower.

3- Apply Ciclopirox Topical Solution, 8% daily over the previous coat. 4- Once a week, remove the Ciclopirox Topical Solution, 8% with alcohol. Remove as much of the damaged nail as possible using scissors, nail clippers, or a nail file.

5- Repeat process (steps 2 through 4). Please Note: 1- To prevent screw cap from sticking to the bottle, do not allow solution to get into the bottle threads. 2- To prevent the solution from drying out, bottle should be closed tightly after every use.

3- To protect from light, replace bottle in carton after each use. Manufactured By Padagis, Yeruham, Israel Distributed By Padagis Allegan, MI 49010 Rev 02-17 • www.padagis.com Rev 03-22 45J00 RC J1 Image 1 Image 2 Image 3 Image 4

📄 Package Label / Principal Display Panel 27 words ▾

Package/Label Display Panel Rx Only NDC 45802- 141 -67 Ciclopirox Topical Solution 8% Nail Lacquer For Dermatologic Use Only Not for Use in Eyes 6.6 mL carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
24.3K
Units reimbursed last 4 qtrs
162.9K
Gross reimbursed last 4 qtrs
$468.6K
Avg / prescription
$19.26
Avg / unit
$2.8764
Latest quarter Q1 2026
5KRx
Medicaid pays / mL
$2.8764
gross reimbursed
vs
NADAC / mL
$1.1541
acquisition cost
=
Spread
+$1.7223
+149% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
64% FFS 36% MCO
Fee-for-service · 15,658 Rx Managed care · 8,666 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 1,135 units · 14.5 per 100k residents WA Idaho: 106 units · 5.4 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 1,089 units · 19.0 per 100k residents MN Wisconsin: 3,557 units · 60.2 per 100k residents WI Michigan: 6,401 units · 63.8 per 100k residents MI New York: 62,708 units · 320 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 198 units · 4.7 per 100k residents OR Nevada: 1,445 units · 45.2 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 73 units · 0.6 per 100k residents IL Indiana: 1,148 units · 16.7 per 100k residents IN Ohio: 6,092 units · 51.7 per 100k residents OH Pennsylvania: 9,101 units · 70.2 per 100k residents PA New Jersey: 14,018 units · 151 per 100k residents NJ Massachusetts: 1,696 units · 24.2 per 100k residents MA California: 33,481 units · 85.9 per 100k residents CA Utah: 332 units · 9.7 per 100k residents UT Colorado: 1,393 units · 23.7 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 1,726 units · 38.1 per 100k residents KY West Virginia: no data reported WV Virginia: 1,597 units · 18.3 per 100k residents VA Maryland: 2,278 units · 36.9 per 100k residents MD Connecticut: 1,135 units · 31.4 per 100k residents CT Rhode Island: 86 units · 7.9 per 100k residents RI Arizona: 2,594 units · 34.9 per 100k residents AZ New Mexico: 317 units · 15.0 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 436 units · 6.1 per 100k residents TN North Carolina: 1,650 units · 15.2 per 100k residents NC South Carolina: 172 units · 3.2 per 100k residents SC Delaware: 449 units · 43.5 per 100k residents DE Oklahoma: no data reported OK Louisiana: 680 units · 14.9 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: 86 units · 12.7 per 100k residents DC Hawaii: no data reported HI Texas: 554 units · 1.8 per 100k residents TX Florida: 5,168 units · 22.9 per 100k residents FL
Units reimbursed · per 100k residents
0.6320
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 320 /100k
2 New Jersey 151 /100k
3 California 85.9 /100k
4 Pennsylvania 70.2 /100k
5 Michigan 63.8 /100k
6 Wisconsin 60.2 /100k
7 Ohio 51.7 /100k
8 Nevada 45.2 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Ciclopirox — the program that covers self-administered drugs. 9 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Ciclopirox. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$6.35M
Claims incl. refills
257.1K
Beneficiaries
197.4K
Spend / beneficiary
$32.18
Spend / claim
$24.71
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Ciclopirox — the ingredient across all brands.

Top reported reactions

Fatigue181
Pain170
Diarrhoea147
Pruritus135
Rash135
Headache133
Dyspnoea115

Age at onset

Neonate1
Child3
Adolescent4
Adult390
Elderly286

Reporter sex

2,937 reports
Male · 45%
Female · 55%
Unknown · 0%

Serious outcomes

Hospitalization763
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 291 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
← 45802-0140-26 · Padagis 45802-0143-01 · Padagis →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.