Penlac Nail Lacquer

Ciclopirox topical solution is used along with regular nail trimming to treat fungal infections of the fingernails and toenails (an infection that may cause nail discoloration, splitting and pain). Ciclopirox is in a class of medications called antifungals. It works by stopping the growth of nail fungus.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Unless your doctor tells you otherwise, continue your normal diet.

Ciclopirox topical solution may cause side effects. Tell your doctor if the following symptom is severe or does not go away:

• redness at the place where you applied ciclopirox

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:

• irritation, itching, burning, blistering, swelling, or oozing at the place where you applied ciclopirox
• pain at the affected nail(s) or surrounding area
• discoloration or change in shape of nail(s)
• ingrown nail(s)

Ciclopirox topical solution may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

• Penlac^® Nail Lacquer

• Dermik Laboratories, Inc.

• DispenseXpress, Inc.

• Valeant Pharmaceuticals North America LLC

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

• unusual or severe itching, redness, burning, dryness, or irritation of treated skin; or

• discoloration or other changes in the nails.

Common side effects may include:

• mild burning, itching, or redness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.