Ciclopirox Kit — NDC 42192-714-01 (Billing 42192-0714-01)
This is a package of Ciclopirox Kit from Acella Pharmaceuticals, LLC, marketed since Oct 2011 and currently FDA-listed; retail pharmacies pay about $7.35 per mL (NADAC). It is this product's only package size.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 067434
- GCN: 29988
- GPI-14 (Medi-Span): 90150030006420
- HICL (First Databank): 037646
- AHFS class code: 84:04.08.20
- RxCUI (RxNorm): 309291
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Other antifungals for topical use class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Ciclopirox topical solution is used along with regular nail trimming to treat fungal infections of the fingernails and toenails (an infection that may cause nail discoloration, splitting and pain). Ciclopirox is in a class of medications called antifungals. It works by stopping the growth of nail fungus.
Read the full MedlinePlus article ↗- 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?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Ciclopirox — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $7.355 | — |
| Medicaid paysCMS SDUD · 12 mo | $372.08 | — |
| Medicare drug plans payPart D · Q2 2026 | $3.03 | — |
Where does this data come from?
- CMS NADAC weekly file · file of Jul 15, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q4 2025
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 42192-0714-01 You're viewing this Main listing | 1 KIT in 1 CARTON * 6.6 mL in 1 BOTTLE, WITH APPLICATOR * 28 mL in 1 BOTTLE | 2011-10-10 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ciclopirox 80 mg/mL 21922-0053-51 | Encube | 1 bottle | $1.154 | AT | Availability likely | save 84% |
| Ciclopirox 80 mg/mL 42192-0715-06 | Acella | 1 bottle | $1.154 | AT | Availability likely | save 84% |
| Ciclopirox 80 mg/mL 45802-0141-67 | Padagis | 1 bottle | $1.154 | AT | Availability likely | save 84% |
| Ciclopiroxthis 42192-0714-01 | Acella | 1 kit | $7.355 | — | Availability likely | — |
| 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 | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Jul 15, 2026
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE (To understand fully the indication for this product, please read the entireINDICATIONS AND USAGE section of the labeling.) Ciclopirox Topical Solution, 8% (Nail Lacquer), 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% (Nail Lacquer) should be used only under medical supervision as described above. The effectiveness and safety of Ciclopirox Topical Solution, 8% (Nail Lacquer) in the following populations has not been studied.
The clinical trials with use of Ciclopirox Topical Solution, 8% (Nail Lacquer) 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% (Nail Lacquer) daily for greater than 48 weeks have not been established.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Ciclopirox Topical Solution, 8% (Nail Lacquer) 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 ).
⛔ Contraindications ▾
CONTRAINDICATIONS Ciclopirox Topical Solution, 8% (Nail Lacquer) is contraindicated in individuals who have shown hypersensitivity to any of its components.
⚠️ Warnings ▾
WARNINGS Ciclopirox Topical Solution, 8% (Nail Lacquer) is not for ophthalmic, oral, or intravaginal use. For use on nails and immediately adjacent skin only.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS In the vehicle-controlled clinical trials conducted in the US, 9% (30/327) of patients treated with Ciclopirox Topical Solution, 8% (Nail Lacquer) 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 anderythema of the proximal nail fold were reported more frequently in patients treated with Ciclopirox Topical Solution, 8% (Nail Lacquer) (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% (Nail Lacquer) 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% (Nail Lacquer) (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% (Nail Lacquer), 32% with the vehicle and 2% with the negative control, but all were reactions of mild transient erythema.
There was no evidence of allergiccontact sensitization for either the Ciclopirox Topical Solution, 8% (Nail Lacquer), or the vehicle base. In a separate study of the photosensitization potential of CiclopiroxTopical Solution, 8% (Nail Lacquer) 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% (NailLacquer) discontinued treatment due to a rash, localized to the palm (causal relation to test material undetermined).
Use of Ciclopirox Topical Solution, 8% (Nail Lacquer) 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% (Nail Lacquer) experienced at least one TEAE that theinvestigator 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 mostfrequently reported.
Four patients discontinued because of TEAEs. Two of the four had events considered to be related to test material: one patient’s great toenail “brokeaway” and another had an elevated creatine phosphokinase level on Day 1 (after 48 weeks of treatment with vehicle in the previous vehicle-controlled study).
🧒 Pediatric Use ▾
Pediatric Use: Based on the safety profile in adults, Ciclopirox Topical Solution, 8% (Nail Lacquer) is considered safe for use in children twelve years and older. No clinical trials have been conducted in the pediatric population.
🧓 Geriatric Use ▾
Geriatric Use: Clinical studies of Ciclopirox Topical Solution, 8% (Nail Lacquer) 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 ▾
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.
🧬 Mechanism of Action ▾
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.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Ciclopirox Treatment Kit NDC (42192-714-01) contains 1 – 6.6 ml bottle of Ciclopirox Topical Solution, 8% (Nail Lacquer) (glass bottle with screw cap which is fitted with a brush), 1 - 28 ml bottle Topical Toe Freshener.
📦 Storage and Handling ▾
Ciclopirox Topical Solution, USP 8% (Nail Lacquer) should be stored at 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (between 59° and 86°F). [See USP, "Controlled Room Temperature."] Protect from light (e.g., store the bottle in the carton after every use). CAUTION: Flammable. Keep away from heat and flame.
📋 Description ▾
DESCRIPTION Ciclopirox Topical Solution, 8% (Nail Lacquer) 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% (Nail Lacquer) contains 80 mg ciclopirox in a solution base consisting of ethyl acetate, NF; isopropyl alcohol, USP;and butyl monoester of poly[methylvinyl ether/maleic acid] in isopropyl alcohol.
Ethyl acetate and isopropyl alcohol are solvents that vaporize after application. Ciclopirox Topical Solution, 8% (Nail Lacquer) 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 molecular 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 Image
💬 Information for Patients ▾
Information for Patients: Patients should have detailed instruction regarding the use of Ciclopirox Topical Solution, 8% (Nail Lacquer) 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: Use Ciclopirox Topical Solution, 8% (Nail Lacquer) as directed by a health care professional. Avoid contact with eyes and mucous membranes.
Contactwith skin other than skin immediately surrounding the treated nail(s) should be avoided. Ciclopirox Topical Solution, 8% (Nail Lacquer) is for external use only. Ciclopirox Topical Solution, 8% (Nail Lacquer) should be applied evenly over the entire nail plate and 5 mm of surrounding skin.
If possible, CiclopiroxTopical Solution, 8% (Nail Lacquer) 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). 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 you have diabetes or problems with numbness in your toes or fingers for consideration of the appropriate nail management program. Inform a health care professional if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, oozing). Up to 48 weeks of daily applications with Ciclopirox Topical Solution, 8% (Nail Lacquer) 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).
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 completely clear or almost clear toenail.
Do not use the medication for any disorder other than that for which it is prescribed. 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.
⚠️ Precautions ▾
PRECAUTIONS If a reaction suggesting sensitivity or chemical irritation should occur with the use of Ciclopirox Topical Solution, 8% (Nail Lacquer) 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.
🍼 Nursing Mothers ▾
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% (Nail Lacquer) is administered to a nursing woman.
🧬 Pharmacokinetics ▾
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 radio labeled 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 5 patients with dermatophytic onychomycoses, after application of Ciclopirox Topical Solution, 8% (Nail Lacquer) 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 4 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% (Nail Lacquer) to all toenails and affected fingernails. Out of a total of 66 randomly selected patients on active treatment, 24 had detectable serum ciclopirox concentrations at some point during the dosing interval (range 10.0-24.6 ng/mL).
It should be noted that eleven of these 24 patients took concomitant medication containing ciclopirox as ciclopirox olamine cream 0.77%. The penetration of the Ciclopirox Topical Solution, 8% (Nail Lacquer) was evaluated in an in vitro investigation. Radiolabeled ciclopirox applied once to onychomycotic toenails that were avulsed demonstrated penetration up to a depth of approximately 0.4 mm.
As expected, nail plate concentrations decreased as a function of nail depth. The clinical significance of these findings in nail plates is unknown. Nail bed concentrations were not determined.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
Carcinogenesis, Mutagenesis, Impairment of Fertility: No carcinogenicity study was conducted with Ciclopirox Topical Solution, 8% (Nail Lacquer), 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 6-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% (Nail Lacquer)) in subjects with distal subungualonychomycosis, 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 thelowest 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 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% (Nail Lacquer): 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 themaximum 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% ((Nail Lacquer)) that will cover all the fingernails andtoenails including 5 mm proximal and lateral fold area plus onycholysis to a maximal extent of 50%.
📚 References ▾
REFERENCES: -Dittmar W., Lohaus G. 1973. HOE296, A new antimycotic compound with a broad antimicrobial spectrum.
Arzneim- Forsch./Drug Res. 23:670-674. -Niewerth et al., 1998. Antimicrobial susceptibility testing of dermatophytes: Comparison of the agar macrodilution and broth micro dilution tests.
Chemotherapy. 44:31-35. -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. Gantrez is a registered trademark of GAF Corporation.
📖 Instructions for Use ▾
Patient Information and Instructions Rx Only Ciclopirox Topical Solution, USP 8% (Nail Lacquer) Patients should have a 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, oozing).
Up to 48 weeks of daily application 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 nail clippers or nail fiels. 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.
(Figure 1A & Figure 1B) 2. Apply ciclopirox topical solution, 8% once daily (preferably at bedtime) 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 medication, wait 8 hours before taking a bath or shower.
(Figure 2) 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 as possible of the damaged nail using scissors, nail clippers, or nail files. (Figure 3) 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 into carton after each use. (Figure 4) Manufactured by: Groupe Parima 4450 Cousens Montreal, Quebec Canada H4S 1X6 Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005 IN-71506.R1 L-0215 Rev. 0526-03 Product of Finland Figure 1A Figure 1B Figure 2 Figure… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
Principal Display Panel - KIT NDC 42192-714-01 Ciclopirox Treatment Kit Ciclopirox Topical Solution, 8% (Nail Lacquer) Topical Toe Freshener Rx Only Contains: 6.6 mL bottle of Ciclopirox Topical Solution, 8% (nail lacquer) 1 - 28 mL bottle Topical Toe Freshener Acella PHARMACEUTICALS, LLC Ciclopirox Kit Carton
Medicaid utilization & spend
Medicare Part D spend CMS · PART D · 2026 (Q1)
Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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About this NDC listing & data coverage
Listed without an FDA application
This product's marketing category indicates it is marketed without an approved FDA application (no NDA, ANDA, or BLA on file). Having an NDC does not by itself establish FDA approval — the NDC Directory is a listing system, not an approval decision. Approval-linked data such as Orange Book therapeutic-equivalence ratings therefore does not apply.
Kit / multi-component package
This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | ✓ Available |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | ✓ Available |