Penciclovir 10 mg/g Cream
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Penciclovir is used on the lips and faces of adults to treat cold sores caused by herpes simplex virus. Penciclovir does not cure herpes infections but decreases pain and itching if applied when the earliest symptoms first appear. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Read the full MedlinePlus article ↗Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Penciclovir — tap one for details:
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII 2DMT128M1S
A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
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UNII T5L8T28FGP
Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
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UNII 4T6H12BN9U
Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
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UNII YRC528SWUY
A waxy emulsifier made from plant-derived fatty alcohols. It helps blend oil and water-based ingredients together and improves how the medicine spreads and absorbs.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
6 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $50.083 | $250.42 / 5 g |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $86.92 | $434.59 / 5 g |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Penciclovir 10 mg/g 00093-3186-20 | Teva | 1 tube | $50.083 | AB | Availability likely | — |
| Penciclovir 10 mg/gthis 00378-0896-55 | Mylan | 1 tube | $50.083 | AB | Availability likely | — |
| Penciclovir 10 mg/g 13668-0661-10 | Torrent | 1 tube | $50.083 | BX | Availability likely | — |
| Penciclovir 10 mg/g 45802-0440-75 | Padagis | 1 tube | $50.083 | AB | Availability likely | — |
| Penciclovir 10 mg/g 69238-1791-07 | Amneal | 1 tube | $50.083 | AB | Availability likely | — |
| Denavir 10 mg/g 00378-9720-55 | Mylan | 1 tube | $155.077 | AB | Availability likely | +210% |
Where does this data come from?
⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00378-0896-55 You're viewing this | 1 TUBE in 1 CARTON (0378-0896-55) / 5 g in 1 TUBE | 2022-11-16 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE 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. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION 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 ( 2 ). • Start treatment as early as possible (i.e., during the prodrome or when lesions appear). ( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Penciclovir cream is supplied in a 5 gram tube containing 10 mg of penciclovir per gram in a cream base, which is equivalent to 1% (w/w). • Topical cream containing 1% penciclovir ( 3 ).
⛔ Contraindications ▾
4 CONTRAINDICATIONS 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. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Only for topical use of herpes labialis on the lips and face. ( 5 )
5.1General 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.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS • One or more local skin reactions were reported by 3% of the subjects treated with penciclovir cream and 4% of placebo-treated patients. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Studies Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In two double-blind, placebo-controlled trials, 1,516 patients were treated with penciclovir cream and 1,541 with placebo. One or more local adverse reactions were reported by 3% of the patients treated with penciclovir cream and 4% of placebo-treated patients.
The rates of reported local adverse reactions are shown in Table 1. TABLE 1 - Local Adverse Reactions Reported in Phase III Trials Penciclovir N = 1,516 % Placebo N = 1,541 % Application site reaction 1 2 Hypesthesia/Local anesthesia < 1 < 1 Taste perversion < 1 < 1 Rash (erythematous) < 1 < 1 Two studies, enrolling 108 healthy subjects, were conducted to evaluate the dermal tolerance of 5% penciclovir cream (a 5-fold higher concentration than the commercial formulation) compared to vehicle using repeated occluded patch testing methodology.
The 5% penciclovir cream induced mild erythema in approximately one-half of the subjects exposed, an irritancy profile similar to the vehicle control in terms of severity and proportion of subjects with a response. No evidence of sensitization was observed.
6.2Post-Marketing Experience The following adverse reactions have been identified during post-approval use of penciclovir cream. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following events have been identified from worldwide post-marketing use of penciclovir cream in treatment of recurrent herpes labialis (cold sores) in adults.
These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to penciclovir cream. General: Headache, oral/pharyngeal edema, parosmia. Skin: Aggravated condition, decreased therapeutic response, local edema, pain, paresthesia, pruritus, skin discoloration, and urticaria.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS No drug interaction studies have been performed with penciclovir cream. Due to minimal systemic absorption of penciclovir, systemic drug interactions are unlikely.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Penciclovir is not absorbed systemically following topical administration and maternal use is not expected to result in fetal exposure to the drug.
8.2Lactation Risk Summary Penciclovir is not absorbed systemically by the mother following topical administration and breastfeeding is not expected to result in exposure of the child to penciclovir.
8.4Pediatric Use An open-label, uncontrolled trial with penciclovir cream 1% was conducted in 102 subjects, ages 12-17 years, with recurrent herpes labialis. The frequency of adverse events was generally similar to the frequency previously reported for adult patients. Safety and effectiveness in pediatric patients less than 12 years of age have not been established.
8.5Geriatric Use In 74 subjects ≥ 65 years of age, the adverse events profile was comparable to that observed in younger patients.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Penciclovir is not absorbed systemically following topical administration and maternal use is not expected to result in fetal exposure to the drug.
🧒 Pediatric Use ▾
8.4Pediatric Use An open-label, uncontrolled trial with penciclovir cream 1% was conducted in 102 subjects, ages 12-17 years, with recurrent herpes labialis. The frequency of adverse events was generally similar to the frequency previously reported for adult patients. Safety and effectiveness in pediatric patients less than 12 years of age have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use In 74 subjects ≥ 65 years of age, the adverse events profile was comparable to that observed in younger patients.
🆘 Overdosage ▾
10 OVERDOSAGE Since penciclovir is poorly absorbed following oral administration, adverse reactions related to penciclovir ingestion are unlikely. There is no information on overdose.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Penciclovir is an antiviral agent active against alpha herpes viruses [see Microbiology (12.4) ].
12.3Pharmacokinetics Measurable penciclovir concentrations were not detected in plasma or urine of healthy male volunteers (n = 12) following single or repeat application of the 1% cream at a dose of 180 mg penciclovir daily (approximately 67 times the estimated usual clinical dose). Pediatric Patients The systemic absorption of penciclovir following topical administration has not been evaluated in patients < 18 years of age.
12.4Microbiology 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.
Antiviral Activity In cell culture studies, penciclovir has antiviral activity against the following herpes viruses: HSV-1 and HSV-2. The antiviral activity of penciclovir against wild type strains grown on human foreskin fibroblasts was assessed with a plaque reduction assay and staining with crystal violet 3 days post-infection for HSV. The median EC 50 values of penciclovir against laboratory and clinical isolates of HSV-1 and HSV-2 were 2 μM (range 1.2 to 2.4 μM, n = 7) and 2.6 μM (range 1.6 to 11 μM, n = 6), respectively.
Resistance In Cell Culture Penciclovir-resistant HSV-1 and HSV-2 strains were isolated in cell culture. Penciclovir-resistant mutants of HSV resulted from mutations in the viral thymidine kinase (TK) and DNA polymerase (POL) genes. Frameshifts were commonly isolated and result in premature truncation of the HSV TK product with decreased enzymatic activity and consequent decreased susceptibility to penciclovir.
Mutations in the viral TK gene may lead to complete loss of TK activity (TK negative), reduced levels of TK activity (TK partial), or alteration in the ability of viral TK to phosphorylate the drug without an equivalent loss in the ability to phosphorylate thymidine (TK altered). In cell culture, the following resistance-associated substitutions in TK of HSV-1 and HSV-2 were observed: HSV-1 TK G6C, F13L, H142Y, G200D, L205S, S254Stop, V267G, and T287M; HSV-2 TK G39E, F191L, E226K, and T288M. The median EC 50 values observed in a plaque reduction assay with penciclovir resistant HSV-1 and HSV-2 were 69 μM (range 14 to 115 μM, n = 6) and 46 μM (range 4 to > 395 μM, n = 9), respectively.
Resistance and Cross-resistance in Clinical Isolates from HSV-Infected Patients Clinical HSV-1 and HSV-2 isolates obtained from patients who failed treatment with acyclovir for their α-herpesvirus infections were evaluated for genotypic changes in the TK and POL genes. These HSV isolates had frameshift mutations leading to loss of thymidine kinase or had substitutions in the viral thymidine kinase and viral DNA polymerase. Phenotypic analysis of these clinical isolates confirmed resistance to penciclovir and acyclovir.
These and other resistance-associated substitutions reported in the literature, or observed in clinical trials, are listed in Table 2. The list is not all inclusive and additional changes will likely be identified in HSV variants isolated from patients who fail penciclovir containing regimens. The possibility of viral resistance to penciclovir should be considered in patients who fail to respond or experience recurrent viral shedding during therapy.
Table 2: Su…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Penciclovir is an antiviral agent active against alpha herpes viruses [see Microbiology (12.4) ].
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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Penciclovir cream is supplied in a 5 gram tube containing 10 mg of penciclovir per gram in a cream base, which is equivalent to 1% (w/w). The white cream is available as follows: NDC 0378-0896-55 carton containing one 5 gram tube Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]
📋 Description ▾
11 DESCRIPTION Penciclovir cream 1% contains penciclovir, an antiviral agent active against herpes viruses. Penciclovir cream is available for topical administration as a 1% white cream. Each gram of penciclovir cream contains 10 mg of penciclovir and the following inactive ingredients: cetostearyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water and white petrolatum.
Chemically, penciclovir is known as 9-[4-hydroxy-3-(hydroxymethyl)butyl] guanine. Its molecular formula is C 10 H 15 N 5 O 3 ; its molecular weight is 253.26. It is a synthetic acyclic guanine derivative and has the following structure: Figure 1: Structural Formula of Penciclovir Penciclovir is a white to pale yellow solid.
At 20°C it has a solubility of 0.2 mg/mL in methanol, 1.3 mg/mL in propylene glycol, and 1.7 mg/mL in water. In aqueous buffer (pH 2) the solubility is 10.0 mg/mL. Penciclovir is not hygroscopic.
Its partition coefficient in n-octanol/water at pH 7.5 is 0.024 (logP = -1.62). Figure 1: Structural Formula of Penciclovir
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Administration Instructions: Advise the patient that treatment should be started at the earliest sign of a cold sore (i.e., tingling, redness, itching, or bump). Inform the patient to apply the cream every 2 hours during waking hours for 4 days and to wash their hands with soap and water after using penciclovir cream. The brands listed are trademarks of their respective owners.
Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Confab Laboratories Inc.
St-Hubert, Canada J3Y 3X3 301647-02 Revised: 9/2019 CON:PENCCRG:R1