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About Cold Sores

If you get cold sores, you may feel alone — but you’re not alone at all. Between 20-40% of Americans suffer from recurrent, cold sores.10

What causes cold sores?

Cold sores are caused by a virus called herpes simplex virus type 1. 6,9 Unlike the virus that causes colds or the flu, the herpes virus stays in your body for life. When the virus is not active and not causing symptoms, it’s called “latent.” But, even when you don’t have symptoms, the virus can become active and cause a cold sore.1,6 (Learn more about cold sore triggers.)

What You Can Do About Them

There is currently no cure for cold sores or the virus that causes them.6 But, for adults and children 12 or older who have recurrent cold sores, Denavir® (penciclovir cream, 1%) can help them heal when they do reappear.4

You can take control. Denavir cream reduces the duration of cold sores and the duration of the pain they cause.4

Be ready. Have prescription Denavir on hand so you’ll be ready to start treating when your next cold sore begins.


Denavir has not been shown to prevent the spread of the virus that causes cold sores, or to prevent cold sore outbreaks.

Symptoms

Cold sore outbreaks often begin with tingling, itching, and/or burning sensations before any visible signs appear.1,6

About a fourth of outbreaks don’t progress beyond the tingle. In those that do progress, a cluster of painful, fluid-filled blisters forms in the area where the tingle occurred. The blisters, which can vary in size, eventually begin to break open, forming erosions that can be tender. The erosions, which are sometimes called lesions, quickly dry out, forming a crust that eventually becomes a scab. The scab becomes smaller as the cold sore heals.1,3,6

Cold sores usually heal within about 2 weeks.1,6 From the time the tingle starts until several days after the cold sore heals, the virus can still be spread to others.6

There are other conditions which may cause lesions that resemble cold sores. If you experience symptoms that may be recurrent cold sores, talk to your doctor or dentist. He or she can provide a diagnosis and discuss your treatment options.


Denavir has not been shown to prevent the spread of the virus that causes cold sores, or to prevent cold sore outbreaks.

Triggers

There’s never a good time to have a cold sore. Still, cold sores seem to appear at inconvenient times — like vacations or times when you’re feeling stressed. That’s because certain situations can activate the cold sore virus, causing a cold sore to develop. Some common triggers include:1

  • Emotional stress
  • Feeling tired or “run-down”
  • Exposure to sun or ultraviolet light
  • Sickness, such as cold or flu
  • Mouth injuries and dental work
  • Hormonal changes, such as menstruation and pregnancy

Talk to your healthcare provider about what may trigger your cold sores. And ask if Denavir® (penciclovir cream, 1%) is right for you.

Be ready. By keeping prescription Denavir on hand, you’ll know you’re ready for your next cold sore outbreak.


Denavir has not been shown to prevent the spread of the virus that causes cold sores, or to prevent cold sore outbreaks.

Glossary

Antiviral: medication that reduces the activity of viruses in the body.

Cold sore: blister-like sores that appear on the lips or face and are caused by the herpes simplex virus; cold sores are sometimes called “fever blisters.”

Herpes simplex virus type 1 (HSV-1): virus that causes cold sores and stays in the body for life; it does not cause symptoms when in an inactive, or latent, state, but may cause cold sores when reactivated.

Latent: in an inactive, or dormant, state; latent herpes simplex virus does not cause symptoms even though it is still present in the body.

Placebo: a treatment used in a clinical study that does not contain medicine.

Recurrent: describes a condition that reappears; recurrent cold sores are caused by reactivation of the herpes simplex virus in the body.

Topical: application to a localized area of the skin.

Virus: microscopic organism that infects cells in the body and can cause infectious diseases and conditions; examples of conditions caused by viruses include colds, the flu, and cold sores.


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.