What is ciclopirox used for?

Indications and Usage, quoted from the label by Acella Pharmaceuticals, LLC (ANDA078172). Cross-references to other label sections are left out.

(To understand fully the indication for this product, please read the entire INDICATION AND USAGE section of the labeling.)

Ciclopirox topical solution, USP 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 ciclopirox topical solution, 8% 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 US. 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.

*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.

* Four patients (from studies 312 and 313) who were completely cured did not have post-treatment Week 12 planimetry data.

Source: DailyMed label, set id a08137a9-331f-4615-9752-e2cb52b3d8fc, version 5, effective July 10, 2026. NDC 42192-715, one of 12 listings for this product.

Indications and Usage, quoted from the label by Glenmark Pharmaceuticals Inc., USA (ANDA091595). Cross-references to other label sections are left out.

Superficial Dermatophyte Infections

Ciclopirox gel is indicated for the topical treatment of interdigital tinea pedis and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum.

Seborrheic Dermatitis

Ciclopirox gel is indicated for the topical treatment of seborrheic dermatitis of the scalp.

Source: DailyMed label, set id 3c22416e-4293-4ba5-a983-137cbc6022db, version 6, effective January 23, 2026. NDC 68462-455, one of 7 listings for this product.

Indications and Usage, quoted from the label by Encube Ethicals, Inc. (ANDA209975). Cross-references to other label sections are left out.

Ciclopirox shampoo, 1 % is indicated for the topical treatment of seborrheic dermatitis of the scalp in adults.

Source: DailyMed label, set id cb456f2e-6645-4cc4-8e71-299c47ccb6b7, version 1, effective January 30, 2026. NDC 21922-105, one of 4 listings for this product.