FAQ


What is a cold sore?
A cold sore is a blister-like sore that appears on the lips or face; cold sores are sometimes called “fever blisters.”
What causes a cold sore?

Cold sores are caused by a virusVirus: 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. called herpes simplex virus type 1Herpes 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.. 3,83. Fatahzadeh M, Schwartz RA. Herpes simplex virus infections: epidemiology, pathogenesis, symptomatology, diagnosis, and management. J Am Acad Dermatol. 2007;57:737-763.

8. Woo S, Challacombe SJ. Management of recurrent oral herpes simplex infections. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007;103(suppl 1):S12.e1-S12.e18.
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.2,32. Arduino PG, Porter SR. Herpes simplex virus type I infection: overview on relevant clinic-pathological features. J Oral Pathol Med. 2008;37:107-121.

3. Fatahzadeh M, Schwartz RA. Herpes simplex virus infections: epidemiology, pathogenesis, symptomatology, diagnosis, and management. J Am Acad Dermatol. 2007;57:737-763.

What triggers a cold sore?

Certain situations can activate the cold sore virus, causing a cold sore to develop. Talk to your healthcare provider about what may trigger your cold sores. Some common triggers include:22. Arduino PG, Porter SR. Herpes simplex virus type I infection: overview on relevant clinic-pathological features. J Oral Pathol Med. 2008;37:107-121.

  • 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
What are the symptoms of a cold sore?

Cold sore outbreaks often begin with tingling, itching, and/or burning sensations before any visible signs appear.2,32. Arduino PG, Porter SR. Herpes simplex virus type I infection: overview on relevant clinic-pathological features. J Oral Pathol Med. 2008;37:107-121.

3. Fatahzadeh M, Schwartz RA. Herpes simplex virus infections: epidemiology, pathogenesis, symptomatology, diagnosis, and management. J Am Acad Dermatol. 2007;57:737-763.
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.2,3,92. Arduino PG, Porter SR. Herpes simplex virus type I infection: overview on relevant clinic-pathological features. J Oral Pathol Med. 2008;37:107-121.

3. Fatahzadeh M, Schwartz RA. Herpes simplex virus infections: epidemiology, pathogenesis, symptomatology, diagnosis, and management. J Am Acad Dermatol. 2007;57:737-763.

9. Cernik C, Gallina K, Brodell RT. The treatment of herpes simplex infections: an evidenced-based review. Arch Intern Med. 2008;168:1137-1144.
From the time the tingle starts until several days after the cold sore heals, the virusVirus: 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. can still be spread to others.33. Fatahzadeh M, Schwartz RA. Herpes simplex virus infections: epidemiology, pathogenesis, symptomatology, diagnosis, and management. J Am Acad Dermatol. 2007;57:737-763.


About Denavir


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.44. Denavir (penciclovir cream, 1%) Prescribing Information. Cranford, NJ: New American Therapeutics, Inc. December 2010.

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.4,64. Denavir (penciclovir cream, 1%) Prescribing Information. Cranford, NJ: New American Therapeutics, Inc. December 2010.

6. Earnshaw DL, Bacon TH, Darlison SJ, et al. Mode of antiviral action of penciclovir in MRC-5 cells infected with herpes simplex virus type 1 (HSV-1), HSV-2, and varicella-zoster virus. Antimicrob Agents Chemother. 1992;36:2747-2757.

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).44. Denavir (penciclovir cream, 1%) Prescribing Information. Cranford, NJ: New American Therapeutics, Inc. December 2010.

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.44. Denavir (penciclovir cream, 1%) Prescribing Information. Cranford, NJ: New American Therapeutics, Inc. December 2010.

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.44. Denavir (penciclovir cream, 1%) Prescribing Information. Cranford, NJ: New American Therapeutics, Inc. December 2010.

How should I apply Denavir?

Apply Denavir with your finger or a cotton swab every 2 hours during waking hours for 4 days.44. Denavir (penciclovir cream, 1%) Prescribing Information. Cranford, NJ: New American Therapeutics, Inc. December 2010.


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.44. Denavir (penciclovir cream, 1%) Prescribing Information. Cranford, NJ: New American Therapeutics, Inc. December 2010.

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.44. Denavir (penciclovir cream, 1%) Prescribing Information. Cranford, NJ: New American Therapeutics, Inc. December 2010.

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 whether 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.44. Denavir (penciclovir cream, 1%) Prescribing Information. Cranford, NJ: New American Therapeutics, Inc. December 2010.


 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 antiviralAntiviral: medication that reduces the activity of viruses in the body. cream approved for the treatment of recurrentRecurrent: describes a condition that reappears; recurrent cold sores are caused by reactivation of the herpes simplex virus in the body. cold sores.44. Denavir (penciclovir cream, 1%) Prescribing Information. Cranford, NJ: New American Therapeutics, Inc. December 2010. It targets cells that are infected with HSV-1, the virus that causes cold sores. 4,64. Denavir (penciclovir cream, 1%) Prescribing Information. Cranford, NJ: New American Therapeutics, Inc. December 2010.

6. Earnshaw DL, Bacon TH, Darlison SJ, et al. Mode of antiviral action of penciclovir in MRC-5 cells infected with herpes simplex virus type 1 (HSV-1), HSV-2, and varicella-zoster virus. Antimicrob Agents Chemother. 1992;36:2747-2757.


Since 1996, Denavir has consistently provided relief for recurrent cold sores in adults and children 12 years of age and older.44. Denavir (penciclovir cream, 1%) Prescribing Information. Cranford, NJ: New American Therapeutics, Inc. December 2010.


Denavir is distributed by Prestium Pharma, Inc. Learn a little more about us.


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




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.

 












DENAVIR is a nucleoside analog HSV DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in adults and children 12 years of age and older.