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Denavir FAQ

What is Denavir used for?

Denavir® (penciclovir cream, 1%) is approved for the treatment of recurrent cold sores in adults and children 12 years of age and older.4

How does Denavir work?

When you apply Denavir, it penetrates the skin to deliver the antiviral medicine, penciclovir, directly to the site of infection. It targets cells that are infected with HSV-1, the virus that causes cold sores, and prevents the virus from reproducing.4,5

What are the side effects of Denavir?

Denavir was well tolerated in clinical studies. The most common side effect with Denavir was headache, which occurred in 5.3% of patients treated with Denavir and 5.8% of those who received a cream that contained no medication (placebo).4

Other side effects with Denavir reported in less than 2% of patients included: application site reactions, decreased sensitivity to touch, local numbness, taste perversion and rash.4

When should I start treatment with Denavir?

When possible, you should start using Denavir at the first sign or symptom of a cold sore. However, unlike some other prescription and over-the-counter cold sore medicines, Denavir can also be started when the blister has formed.4

How should I apply Denavir?

Apply Denavir with your finger or a cotton swab every 2 hours during waking hours for 4 days.4

Wash your hands. Your face should be clean and dry. Apply a layer of Denavir to cover only the cold sore area or the area of tingling (or other symptoms) before the cold sore appears. Rub in the cream until it disappears. Wash your hands with soap and water after using Denavir. Particular care should be taken to avoid application in or near the eyes since it may cause irritation.4

Can Denavir be used for sores inside the mouth?

Denavir is a topical cream that is to be applied externally only on the lips and face. It is not indicated for internal use inside the mouth, nose, genital or rectal areas.4

Is Denavir a prescription product or can it be obtained over the counter?

Denavir is available by prescription only. Talk to your doctor or dentist to discuss if Denavir may benefit you.

Where can I find the Denavir Full Prescribing Information?

View the Denavir Full Prescribing Information. If you have additional questions about Denavir, please ask your doctor or dentist.

Can Denavir be used for longer than 4 days?

The safety and efficacy of Denavir beyond 4 days has not been studied. If your symptoms do not improve or if they worsen, call your doctor or dentist.4


Denavir selectively targets cells infected with HSV-1 and prevents the virus from reproducing.

Denavir History

Did you know that Denavir® (penciclovir cream, 1%) has been shortening the duration of cold sores for longer than any other prescription cold sore cream in the U.S.? Denavir was the first prescription antiviral cream approved for the treatment of recurrent cold sores.4 It targets cells that are infected with HSV-1, the virus that causes cold sores. 4,5

Since 1996, Denavir has consistently provided relief for recurrent cold sores in adults and children 12 years of age and older.4

Denavir is distributed by New American Therapeutics, Inc. A new kind of pharmaceutical company, New American Therapeutics focuses on patient care and strives to make effective therapeutics work even better for patients.

Learn a little more about us.


Denavir selectively targets cells infected with HSV-1 and prevents the virus from reproducing.


Expand Safety Information

Denavir® (penciclovir cream, 1%) is indicated for the treatment of recurrent herpes labialis
(cold sores) in adults and children 12 years of age and older.

Important Safety Information

Denavir should only be used on herpes labialis on the lips or face. Application to mucous membranes is not recommended. Denavir should not be used in patients with known hypersensitivity to the product or any of its ingredients.

There are no adequate and well-controlled Denavir studies in pregnant women; therefore, Denavir should be used during pregnancy only if clearly needed. There is no information on whether Denavir is excreted in human milk after topical administration; a decision whether to discontinue Denavir should take into account the importance of the drug to the mother. The effect of Denavir has not been established in immunocompromised patients. Denavir does not cure cold sores.

In clinical studies, the most common adverse reaction with Denavir was headache, which occurred in 5.3% of patients who received Denavir and 5.8% of patients who received placebo. Other adverse reactions with Denavir occurred in less than 2% of patients and included application site reaction, decreased sensitivity to touch/local anesthesia, taste perversion, and rash.

Other reported adverse reactions have included swelling of the mouth or throat, pain, alterations in sense of smell, abnormal touch sensation, itching, skin discoloration, and hives.

Denavir is available by prescription only. Please see the Full Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.