Molecule
Penciclovir is a herpesvirus nucleoside analog DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in adults and children 12 years of age or older. It is available as cream for topical use. MedsAcross supplies Penciclovir for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
Penciclovir cream is a deoxynucleoside analog HSV DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in adults and children 12 years of age or older. Penciclovir cream is a deoxynucleoside analog HSV DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in adults and pediatric patients 12 years of age and older.
Source: US FDA prescribing information
Penciclovir is an antiviral agent active against alpha herpes viruses. Mechanism of Action Penciclovir has inhibitory activity against herpes simplex virus types 1 (HSV-1) and 2 (HSV-2). In cells infected with HSV-1 or HSV-2, the viral thymidine kinase phosphorylates penciclovir to a monophosphate form that, in turn, is converted by cellular kinases to the active form penciclovir triphosphate. Biochemical studies demonstrate that penciclovir triphosphate inhibits HSV DNA polymerase competitively with deoxyguanosine triphosphate. Consequently, α-herpes viral DNA synthesis and, therefore, replication are selectively inhibited. Penciclovir triphosphate has an intracellular half-life of 10 hours in HSV-1 and 20 hours in HSV-2 infected cells grown in culture. However, the clinical significance of the intracellular half-life is unknown.
Source: US FDA prescribing information
Apply penciclovir cream every 2 hours during waking hours for a period of 4 days. Start treatment as early as possible (i.e., during the prodrome or when lesions appear). • Apply penciclovir cream every 2 hours during waking hours for a period of 4 days. • Start treatment as early as possible (i.e., during the prodrome or when lesions appear).
Source: US FDA prescribing information
Penciclovir cream is contraindicated in patients with known hypersensitivity to the product or any of its components. • Contraindicated in patients with known hypersensitivity to the product or any of its components.
Source: US FDA prescribing information
• Only for topical use of herpes labialis on the lips and face. General Penciclovir cream should only be used on herpes labialis on the lips and face. Because no data are available, application to human mucous membranes is not recommended. Particular care should be taken to avoid application in or near the eyes since it may cause irritation. Lesions that do not improve or that worsen on therapy should be evaluated for secondary bacterial infection. The effect of penciclovir cream has not been established in immunocompromised patients.
Source: US FDA prescribing information
• One or more local skin reactions were reported by 3% of the subjects treated with penciclovir cream and 4% of placebo-treated patients.
Source: US FDA prescribing information
No drug interaction studies have been performed with penciclovir cream. Due to minimal systemic absorption of penciclovir, systemic drug interactions are unlikely.
Source: US FDA prescribing information
Store at 20º to 25ºC (68º to 77ºF).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Penciclovir, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Penciclovir 1% creamTopicalGeneric name | — | US FDA | Available on request |
| Denavir 1% creamTopical | Mylan Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 24 September 1996 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Penciclovir in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 2 presentations of Penciclovir and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Penciclovir, including Denavir.
Yes. The US FDA first approved Penciclovir on 24 September 1996, according to Drugs@FDA.
No listed presentation of Penciclovir is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Penciclovir is classified under ATC code D06BB06 (Penciclovir).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.