CICLOPIROX

Product Type: HUMAN PRESCRIPTION DRUG

Route: TOPICAL

Dosage Form:

NDC: 63629-8620

Application: ANDA078266

Effective: 20230717

INDICATIONS AND USAGE Superficial Dermatophyte Infections Ciclopirox Gel, 0.77% 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, 0.77% is indicated for the topical treatment of seborrheic dermatitis of the scalp.

DOSAGE AND ADMINISTRATION Superficial Dermatophyte Infections Gently massage Ciclopirox Gel, 0.77% into the affected areas and surrounding skin twice daily, in the morning and evening immediately after cleaning or washing the areas to be treated. Interdigital tinea pedis and tinea corporis should be treated for 4 weeks. If a patient shows no clinical improvement after 4 weeks of treatment, the diagnosis should be reviewed. Seborrheic Dermatitis of the Scalp Apply Ciclopirox Gel, 0.77% to affected scalp areas twice daily, in the morning and evening for 4 weeks. Clinical improvement usually occurs within the first week with continuing resolution of signs and symptoms through the fourth week of treatment. If a patient shows no clinical improvement after 4 weeks of treatment, the diagnosis should be reviewed.

CONTRAINDICATIONS Ciclopirox Gel, 0.77% is contraindicated in individuals who have shown hypersensitivity to any of its components.

WARNINGS Ciclopirox Gel, 0.77% is not for ophthalmic, oral, or intravaginal use. Keep out of reach of children.

ADVERSE REACTIONS In clinical trials, 140 (39%) of 359 subjects treated with Ciclopirox Gel, 0.77% reported adverse experiences, irrespective of relationship to test materials, which resulted in 8 subjects discontinuing treatment. The most frequent experience reported was skin burning sensation upon application, which occurred in approximately 34% of seborrheic dermatitis patients and 7% of tinea pedis patients. Adverse experiences occurring between 1% to 5% were contact dermatitis and pruritus. Other reactions that occurred in less than 1% included dry skin, acne, rash, alopecia, pain upon application, eye pain, and facial edema.