What is Ciclopirox used for?

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 unatt

How does Ciclopirox work?

DESCRIPTION Ciclopirox Topical Solution, 8% contains a synthetic antifungal agent, ciclopirox.

What is the active ingredient in Ciclopirox?

Ciclopirox olaminum (Ciclopirox olaminum)

What pharmaceutical form is Ciclopirox available in?

Ciclopirox: Krem dopochwowy 10 mg/g (dopochwowa)

Is Ciclopirox OTC or prescription only?

Ciclopirox requires a doctor's prescription.

What are the side effects of Ciclopirox?

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% (27/3

Who should NOT take Ciclopirox?

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

Can Ciclopirox be used during pregnancy?

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 ap

What precautions should be taken with Ciclopirox?

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

What ATC class does Ciclopirox belong to?

Ciclopirox: ATC G01AX12. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

Ciclopirox

10 mg/g, Krem dopochwowy

INN: Ciclopirox olaminum

Data updated: 2026-04-13

Available in:

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Form

Krem dopochwowy

Dosage

10 mg/g

Route

dopochwowa

Storage

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.

About This Product

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