Penlac is an antifungal medicine that prevents fungus from growing on your skin.

Penlac nail lacquer is used to treat fungal infections of the toenails and fingernails.

Penlac may also be used for purposes not listed in this medication guide.

Use Penlac for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics.

Avoid getting Penlac nail lacquer in your eyes, nose, or mouth. If this does happen, rinse with water.

Before taking this medicine

You should not use Penlac if you are allergic to ciclopirox.

To make sure Penlac is safe for you, tell your doctor if you have:

• diabetes;

• epilepsy or other seizure disorder;

• a weak immune system (caused by disease or by using certain medicines); or

• a condition for which you use steroid medication (including skin conditions or breathing disorders).

Penlac is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether ciclopirox topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not use this medicine on a child without medical advice. Penlac nail lacquer is not approved for use by anyone younger than 12 years old.

Use Penlac nail lacquer exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

To use Penlac nail lacquer:

• Use on the nails and immediately surrounding skin only. Avoid contact with other areas. Remove any loose nail or nail material using nail clippers or a nail file.

• Apply Penlac nail lacquer once daily (preferably at bedtime) to all affected nails with the applicator brush provided. Apply the lacquer evenly over the entire nail. Where possible, apply the nail lacquer to the underside of the nail and to the skin beneath it. Allow the lacquer to dry (approximately 30 seconds) before putting on socks or stockings. After applying the medication, wait 8 hours before taking a bath or shower.

• Apply Penlac nail lacquer daily over the previous coat. Once a week, remove the nail lacquer with alcohol. Remove as much as possible of the damaged nail using nail clippers or nail a file.

• To prevent the screw cap from sticking to the bottle, do not allow the solution to get into the bottle treads. To prevent the solution from drying out, close the bottle tightly after every use.

Treatment with this medicine may require several months before initial improvement of symptoms is noticed. Up to 48 weeks of daily application of the nail lacquer, monthly removal of the unattached infected nail by a health care professional, and weekly trimming by the patient may be required for complete treatment.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antifungal medicine.

Store Penlac nail lacquer at room temperature away from moisture, heat, and light.

Penlac nail lacquer is flammable. Avoid using near open flame, and do not smoke until the lacquer has completely dried on your skin.

You should not use Penlac if you are allergic to ciclopirox.

To make sure Penlac is safe for you, tell your doctor if you have:

• diabetes;

• epilepsy or other seizure disorder;

• a weak immune system (caused by disease or by using certain medicines); or

• a condition for which you use steroid medication (including skin conditions or breathing disorders).

Penlac is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether ciclopirox topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not use this medicine on a child without medical advice. Penlac nail lacquer is not approved for use by anyone younger than 12 years old.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

An overdose of Penlac is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

Avoid contact with the eyes, nose, and inside of the mouth. If this does happen, rinse with water.

Avoid using other medications on the areas you treat with Penlac unless your doctor tells you to.

Do not use nail polish, artificial nails, or other cosmetic nail products on the nails treated with Penlac nail lacquer.

Avoid wearing tight-fitting, synthetic clothing that doesn't allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Get emergency medical help if you have signs of an allergic reaction to Penlac nail lacquer: 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 Penlac 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.