Denavir is an antiviral medication.

Denavir is a prescription cream used to treat cold sores on the lips that are caused by the herpes simplex virus. This medicine is for adults and children who are at least 12 years old.

Denavir is not a cure for cold sores and you may continue to have them in the future.

Do not apply the cream to the inside of the nose or in or near the eyes.

Use Denavir exactly as directed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not take by mouth. Topical medicine is for use only on the lips and face. If this medicine gets in your nose or mouth, rinse with water.

Denavir should be used to treat cold sores on the lips and face only.

For best results, start using penciclovir as soon as possible after you notice symptoms of a developing cold sore (tingling, redness, itching, or a bump).

Wash your hands before and after applying Denavir cream. Also wash and dry the skin area to be treated.

Apply a thin layer of penciclovir to the cold sore area. Use enough medicine to cover only the cold sore itself, or the skin where you feel tingling or early symptoms of a developing cold sore. Rub in gently until the medicine disappears.

Do not apply Denavir cream to the inside of your nose or near your eyes.

Denavir cream is usually applied every 2 hours throughout the day for 4 days in a row. Follow your doctor's dosing instructions very carefully.

Call your doctor if your symptoms do not improve, or if they get worse.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Herpes Simplex Labialis:

Apply cream to affected area every 2 hours while awake
Duration of therapy: 4 days

Comments: Treatment should begin as early as possible (i.e., during the prodrome or when lesions appear).

Use: For the treatment of recurrent herpes labialis (cold sores)

Usual Pediatric Dose for Herpes Simplex Labialis:

12 years or older: Apply cream to affected area every 2 hours while awake
Duration of therapy: 4 days

Comments: Treatment should begin as early as possible (i.e., during the prodrome or when lesions appear).

Use: For the treatment of recurrent herpes labialis (cold sores)

You should not use Denavir cream if you are allergic to penciclovir.

Since penciclovir topical (for the skin) is not absorbed into the body, using this medicine is not expected to be harmful if you are pregnant or breast-feeding.

Denavir cream is not approved for use by anyone younger than 12 years old.

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

An overdose of Denavir cream 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.

Do not apply Denavir to the inside of your nose or near your eyes. Rinse with water if this medicine does get in your eyes.

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

Call your doctor at once if you have severe skin redness, itching, rash, or pain after applying this medicine.

Common Denavir side effects may include:

• numbness or tingling where the medicine was applied;

• headache; or

• changes in your sense of taste.

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.

It is not likely that other drugs you take orally or inject will have an effect on topically applied penciclovir. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.