Acyclovir
50 mg/g · Ointment
- Prescription only
- Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor
- Active substance
- Acyclovir
- Made by
- ACTAVIS PHARMA, INC.
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2020-10-31
Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor
- Acyclovir Ointment 5% is indicated in the management of initial genital herpes and in limited non-lifethreatening mucocutaneous HSV infections in immunocompromised patients.
Acyclovir Ointment 5% is contraindicated in patients who develop hypersensitivity to the components of the formulation.
All warnings ↓- Prescription only
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
- Acyclovir Ointment 5% is indicated in the management of initial genital herpes and in limited non-lifethreatening mucocutaneous HSV infections in immunocompromised patients.
From the official label · 2020-10-31 · DailyMed
How it works
From this product’s own US prescribing label.
Two clinical pharmacology studies were performed with acyclovir ointment 5% in immunocompromised adults at risk of developing mucocutaneous HSV infections or with localized varicella zoster infections.
These studies were designed to evaluate the dermal tolerance, systemic toxicity, and percutaneous absorption of acyclovir.
Acyclovir excreted in the urine ranged from <0.02% to 9.4% of the daily dose.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2020-10-31
Do not take it if
Acyclovir Ointment 5% is contraindicated in patients who develop hypersensitivity to the components of the formulation.
Quoted from the official label, section “Contraindications”.
How to take it
These directions are for this exact strength and form. Another one is different.
- Apply sufficient quantity to adequately cover all lesions every 3 hours, 6 times per day for 7 days.
- The dose size per application will vary depending upon the total lesion area but should approximate a one-half inch ribbon of ointment per 4 square inches of surface area.
- A finger cot or rubber glove should be used when applying acyclovir to prevent autoinoculation of other body sites and transmission of infection to other persons.
- Therapy should be initiated as early as possible following onset of signs and symptoms.
Quoted from the official label, section “Dosage & Administration”.
Other warnings
- Acyclovir Ointment 5% is intended for cutaneous use only and should not be used in the eye.
- General:
- The recommended dosage, frequency of applications, and length of treatment should not be exceeded (see DOSAGE AND ADMINISTRATION ).
- There are no data to support the use of Acyclovir Ointment 5% to prevent transmission of infection to other persons or prevent recurrent infections when applied in the absence of signs and symptoms.
- Acyclovir Ointment 5% should not be used for the prevention of recurrent HSV infections.
- Although clinically significant viral resistance associated with the use of Acyclovir Ointment 5% has not been observed, this possibility exists.
- Drug Interactions:
- Carcinogenesis, Mutagenesis, Impairment of Fertility:
- Systemic exposure following topical administration of acyclovir is minimal.
- Dermal carcinogenicity studies were not conducted.
- Results from the studies of carcinogenesis, mutagenesis, and fertility are not included in the full prescribing information for Acyclovir Ointment 5% due to the minimal exposures of acyclovir that result from dermal application.
- Information on these studies is available in the full prescribing information for ZOVIRAX ® Capsules, Tablets, and Suspension and ZOVIRAX ® for Injection.
- Pregnancy:
- Nursing Mothers:
- Geriatric Use:
- Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
- General:
- The recommended dosage, frequency of applications, and length of treatment should not be exceeded (see DOSAGE AND ADMINISTRATION ).
- There are no data to support the use of Acyclovir Ointment 5% to prevent transmission of infection to other persons or prevent recurrent infections when applied in the absence of signs and symptoms.
- Acyclovir Ointment 5% should not be used for the prevention of recurrent HSV infections.
- Although clinically significant viral resistance associated with the use of Acyclovir Ointment 5% has not been observed, this possibility exists.
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
- Teratogenic Effects:
- Acyclovir was not teratogenic in the mouse, rabbit, or rat at exposures greatly in excess of human exposure.
- There are no adequate and well-controlled studies of systemic acyclovir in pregnant women.
- A prospective epidemiologic registry of acyclovir use during pregnancy was established in 1984 and completed in April 1999.
- There were 749 pregnancies followed in women exposed to systemic acyclovir during the first trimester of pregnancy resulting in 756 outcomes.
- The occurrence rate of birth defects approximates that found in the general population.
- However, the small size of the registry is insufficient to evaluate the risk for less common defects or to permit reliable or definitive conclusions regarding the safety of acyclovir in pregnant women and their developing fetuses.
- Systemic acyclovir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
- It is not known whether topically applied acyclovir is excreted in breast milk.
- Systemic exposure following topical administration is minimal.
- After oral administration of Acyclovir, acyclovir concentrations have been documented in breast milk in two women and ranged from 0.6 to 4.1 times the corresponding plasma levels.
- These concentrations would potentially expose the nursing infant to a dose of acyclovir up to 0.3 mg/kg/day.
- Nursing mothers who have active herpetic lesions near or on the breast should
- avoid nursing.
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
Other medicines
Clinical experience has identified no interactions resulting from topical or systemic administration of other drugs concomitantly with Acyclovir Ointment 5%.
Quoted from the official label, section “Drug Interactions”.
If you take too much
In an emergency, call your local emergency number or a poison control centre.
Overdosage by topical application of Acyclovir Ointment 5% is unlikely because of limited transcutaneous absorption (see CLINICAL PHARMACOLOGY ).
Quoted from the official label, section “Overdosage”.
Use in children
Safety and effectiveness in pediatric patients have not been established.
Quoted from the official label, section “Pediatric Use”.
Use in older people
- Clinical studies of Acyclovir Ointment did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
- Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
- Systemic absorption of acyclovir after topical administration is minimal (see CLINICAL PHARMACOLOGY ).
Quoted from the official label, section “Geriatric Use”.
Side effects
- In the controlled clinical trials, mild pain (including transient burning and stinging) was reported by about 30% of patients in both the active and placebo arms; treatment was discontinued in two of these patients.
- Local pruritus occurred in 4% of these patients.
- In all studies, there was no significant difference between the drug and placebo group in the rate or type of reported adverse reactions nor were there any differences in abnormal clinical laboratory findings.
- Observed During Clinical Practice:
- Based on clinical practice experience in patients treated with Acyclovir Ointment in the U.S., spontaneously reported adverse events are uncommon.
- Data are insufficient to support an estimate of their incidence or to establish causation.
- These events may also occur as part of the underlying disease process.
- Voluntary reports of adverse events that have been received since market introduction include:
- General:
- Edema and/or pain at the application site.
- Skin: Pruritus, rash.
- To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Quoted from the official label, section “Adverse Reactions”.
What it looks like and how it is packed
- Each gram of Acyclovir Ointment 5% contains 50 mg acyclovir in a polyethylene glycol base. It is supplied as follows:
- 30 g tubes NDC 0591-1159-30
- Store at 15° to 25°C (59° to 77°F) in a dry place.
Quoted from the official label, section “How Supplied”.
How to store it
Store at 15° to 25°C (59° to 77°F) in a dry place.
Quoted from the official label, section “Storage and Handling”.
What is in it
- Acyclovir is a synthetic nucleoside analogue active against herpes viruses.
- Acyclovir Ointment 5% is a formulation for topical administration.
- Each gram of Acyclovir Ointment 5% contains 50 mg of acyclovir in a polyethylene glycol (PEG) base.
- Acyclovir is a white to off-white crystalline powder with the molecular formula C 8 H 11 N 5 O 3 and a molecular weight of 225.20.
- The maximum solubility in water at 37°C is 2.5 mg/mL.
- The pka’s of acyclovir are 2.27 and 9.25.
- The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6 H -purin-6-one; it has the following structural formula:
- Chemical Structure
Quoted from the official label, section “Description”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Every version of this medicine (29)
The same active substance, strength and kind of form, from every company that sells it — with what each label lists.
Showing 29 of 29
- AcyclovirThis onePrescription onlyACTAVIS PHARMA, INC.No ingredient list on the stored label
- AcyclovirPrescription onlyA-S Medication SolutionsNo ingredient list on the stored label
- AcyclovirPrescription onlyAlembic Pharmaceuticals Inc.No ingredient list on the stored label
- AcyclovirPrescription onlyAlembic Pharmaceuticals Inc.Names none of these
- AcyclovirPrescription onlyAmneal Pharmaceuticals LLCNo ingredient list on the stored label
- AcyclovirPrescription onlyAmneal Pharmaceuticals LLCNames none of these
- AcyclovirPrescription onlyAryeh Pharma CorpNo ingredient list on the stored label
- ZoviraxPrescription onlyBausch Health US, LLCNo ingredient list on the stored label
- ZoviraxPrescription onlyBausch Health US, LLCNames none of these
- AcyclovirPrescription onlyBryant Ranch PrepackNo ingredient list on the stored label
- AcyclovirPrescription onlyBryant Ranch PrepackNames none of these
- AcyclovirPrescription onlycNo ingredient list on the stored label
- AcyclovirPrescription onlyGlenmark Pharmaceuticals Inc., USANo ingredient list on the stored label
- AcyclovirPrescription onlyMacleods Pharmaceuticals LimitedNo ingredient list on the stored label
- AcyclovirPrescription onlyNorthstar Rx LLCNo ingredient list on the stored label
- AcyclovirPrescription onlyNuCare Pharmaceuticals, Inc.No ingredient list on the stored label
- AcyclovirPrescription onlyPadagis Israel Pharmaceuticals LtdNames none of these
- AcyclovirPrescription onlyPreferred Pharmaceuticals IncNo ingredient list on the stored label
- AcyclovirPrescription onlySolco Healthcare US, LLCNo ingredient list on the stored label
- AcyclovirPrescription onlySportpharm LLCNo ingredient list on the stored label
- AcyclovirPrescription onlySun Pharmaceutical Industries, Inc.No ingredient list on the stored label
- AcyclovirPrescription onlySun Pharmaceutical Industries, Inc.Names none of these
- AcyclovirPrescription onlyTeva Pharmaceuticals USA, Inc.Names none of these
- AcyclovirPrescription onlyTorrent Pharmaceuticals LimitedNo ingredient list on the stored label
- AcyclovirPrescription onlyViona Pharmaceuticals IncNo ingredient list on the stored label
- AcyclovirPrescription onlyViona Pharmaceuticals IncNames none of these
- AcyclovirPrescription onlyXiromed, LLCNo ingredient list on the stored label
- AcyclovirPrescription onlyZydus Lifesciences LimitedNo ingredient list on the stored label
- AcyclovirPrescription onlyZydus Lifesciences LimitedNo ingredient list on the stored label
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
Spain18 matching products
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- LAVIRK 50 mg/g · gelWithout prescription
- VIRUDERM 50 mg/g · pomadaWithout prescription
- ZOVICREM LABIAL 50 mg aciclovir/ g · cremaWithout prescription
- ACICLOVIR ARISTO 50 mg/g · crema
- ACICLOVIR AUROVITAS 50 mg/g · crema
CanadaNo exact match for this strength and form
Netherlands13 matching products
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- Aciclovir CF 50 mg/g 50 mg/g · crème
- Aciclovir ratiopharm 50 mg/g 50 mg/g · crème
- Aciclovir Teva koortslipcrème 50 mg/g 50 mg/g · crème
- Albert Heijn Koortslipcrème Aciclovir 50 mg/g 50 mg/g · crème
- DA Koortslipcrème Aciclovir 50 mg/g 50 mg/g · crème
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Details
| Made by | ACTAVIS PHARMA, INC. |
|---|---|
| Active substance | Acyclovir |
| Used in | Antibiotics, antivirals and antifungals taken into the body |
| Strength | 50 mg/g |
| Form | Ointment |
| Route | Topical |
| Packs | 1 TUBE in 1 CARTON / 30 g in 1 TUBE |
| NDC | 0591-1159 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
125 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Tablet62 products
- Capsule22 products
- Ointment19 products
50 mg/g19
50 mg/g · 19 companies
- A-S Medication Solutions
- ACTAVIS PHARMA, INC. · this page
- Alembic Pharmaceuticals Inc.
- Amneal Pharmaceuticals LLC
- Aryeh Pharma Corp
- Bryant Ranch Prepack
- c
- Glenmark Pharmaceuticals Inc., USA
- Cream8 products
Show all forms · 7 forms
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.