FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. Ciclopirox is a synthetic broad-spectrum antifungal agent that inhibits the growth of dermatophytes, a type of fungus that grows on the skin, hair, and nails. Simple daily activities such as walking can cause discomfort and pain for individuals with nail fungus disease. Nails may become opaque, white, thickened, and brittle, and may be easily broken.
Infected nails can provide a reservoir of dermatophytes that can cause repeated infections.
Penlac Nail Lacquer is applied once a day with an applicator brush to all affected nails and immediately adjacent skin. Daily applications should be made over the previous coat and removed every seven days. Up to 48 weeks of daily applications, weekly trimming by the patient, and monthly professional removal of the unattached, infected nail, is needed. Penlac Nail Lacquer was developed to provide topical therapy without systemic side effects. In controlled clinical trials it was found to be safe and effective in treating nail fungus, with some patients experiencing resolution of the infection.