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Ciclodan (Ciclopirox): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx)
Strength:
2.28 g/mL
Other brand names:
Active ingredient:

Patient information: uses, side effects, how to take - Ciclodan

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%, (Nail Lacquer), as directed by your health care professional.
  • Ciclopirox Topical Solution, 8%, (Nail Lacquer), 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 applications with Ciclopirox Topical Solution, 8%, (Nail Lacquer), 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
  • Before starting treatment, remove any loose nail or nail material using nail clippers or nail files. 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.
  • Apply Ciclopirox Topical Solution, 8%, (Nail Lacquer), 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.
  • Apply Ciclopirox Topical Solution, 8%, (Nail Lacquer), daily over the previous coat.
  • Once a week, remove the Ciclopirox Topical Solution, 8%, (Nail Lacquer), with alcohol. Remove as much as possible of the damaged nail using scissors, nail clippers, or nail files.
  • Repeat process (steps 2 through 4).
Please Note:
  • To prevent screw cap from sticking to the bottle, do not allow solution to get into the bottle threads.
  • To prevent the solution from drying out, bottle should be closed tightly after every use.
  • To protect from light, replace bottle into carton after each use.

Manufactured for:

MEDIMETRIKS

PHARMACEUTICALS, INC.

383 Route 46 West, Fairfield, NJ 07004 www.medimetriks.com

Manufactured by:

Cosette Pharmaceuticals, Inc.

111 Coolidge Street, South Plainfield, NJ 07080

8-0317MDM5

Rev. 10/2019

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 078233 · View the label on DailyMed

Revision date stated in the text: October 2019

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Ciclodan

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Active ingredient Ciclopirox 2.28 g/mL
Dosage form Solution
Route Topical
Marketing status not in the current FDA NDC Directory
Company (applicant) COSETTE PHARMS NC
FDA approval ANDA 078233Abbreviated New Drug Application (ANDA) – generic drug Approved September 18, 2007
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
2.28 g/mL – 6.6 ml in 1 bottle, with applicator NDC 43538-500-06

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.