Ciclopirox Olamine

Ciclopirox olamine cream is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; candidiasis (moniliasis) due to Candida albicans; and tinea (pityriasis) versicolor due to Malassezia furfur.

• Gently massage ciclopirox olamine cream into the affected and surrounding skin areas twice daily, in the morning and evening
• Clinical improvement with relief of pruritus and other symptoms usually occurs within the first week of treatment
• If a patient shows no clinical improvement after four weeks of treatment with ciclopirox olamine cream, the diagnosis should be redetermined
• Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment

• Safety and effectiveness
• In pediatric patients below the age of 10 years have not been established

• The patient should be told to: 1
• Use the medication for the full treatment time even though symptoms may have improved and notify the physician if there is no improvement after four weeks. 2
• Inform the physician if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, or oozing) indicative of possible sensitization. 3
• Avoid the use of occlusive wrappings or dressings

Ciclopirox olamine cream is contraindicated in individuals who have shown hypersensitivity to any of its components.

Ciclopirox olamine cream is not for ophthalmic use. Keep out of reach of children.

In all controlled clinical studies with 514 patients using ciclopirox olamine cream and in 296 patients using the vehicle cream, the incidence of adverse reactions was low. This included pruritus at the site of application in one patient and worsening of the clinical signs and symptoms in another patient using ciclopirox olamine cream and burning in one patient and worsening of the clinical signs and symptoms in another patient using the vehicle cream. To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

STORAGE Store at 20-25ºC (68-77ºF) [see USP Controlled Room Temperature]. Manufactured by Padagis ® Yeruham, Israel www.padagis.com Rev 03-26 3D914 RC I PH3 PADAGIS is a registered trademark of Padagis US LLC.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.