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.

†Subject to eligibility restrictions and limitations. This offer is not valid for prescriptions reimbursed in whole or in part by Medicaid, Medicare, or any other federal or state program (including any prescription drug programs). This offer is not valid in Massachusetts except for cash-paying patients, or where otherwise prohibited by law.

References
1. Denavir (penciclover cream 1%) Prescribing Information, Cranford, NJ, New American Therapeutics, Inc. December 2010. 2. Boon R, Goodman JJ, Martinez J, et al. for the Penciclovir Cream Herpes Labialis Study Group. Penciclovir cream for the treatment of sunlight-induced herpes labialis: a randomized, double-blind, placebo-controlled trial. Clin Ther. 2000;22:76-90. 3. 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. 4. Hasler-Nguyen N, Shelton D, Ponard G, Bader M, Schaffrik M, Mallefet P. Evaluation of the in vitro skin penetration of antiviral drugs from penciclovir 1% cream and acyclovir 5% cream used to treat herpes simplex virus infection. BMC Dermatol. 2009;9:3. 5. Valtrex (valacyclovir hydrochloride) Prescribing Information. Research Triangle Park, NC: GlaxoSmithKline. September 2008. 6. Famvir (famciclovir) Prescribing Information. East Hanover, NJ: Novartis Pharmaceuticals Corporation. December, 2009. 7. New American Therapeutics. Data on file. (MediMedia Formulary Data, October 2010).

New Amercan Therapeutics, Inc. holds the exclusive right to market and distribute Denavir in the United States. Denavir^® is a registered trademark of New American Therapeutics, Inc.