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Zovirax Topical Cream: Uses, Side Effects and Dosage

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Facts
Status:
Prescription (Rx)
Strength:
50 mg/g
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Active ingredient:
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Zovirax Topical Cream

What is ZOVIRAX Cream?

  • ZOVIRAX Cream is a prescription medicine used to treat cold sores (herpes labialis) that are recurring in adults and children 12 years of age and older, and who have normal immune systems.
  • ZOVIRAX Cream is not a cure for cold sores.

It is not known if ZOVIRAX Cream is safe and effective in children less than 12 years of age.

Do not use ZOVIRAX Cream if you are allergic to acyclovir, valacyclovir, or any of the ingredients in ZOVIRAX Cream. See the end of this leaflet for a complete list of ingredients in ZOVIRAX Cream.

What should I tell my healthcare provider before using ZOVIRAX Cream?

Before using ZOVIRAX Cream, tell your healthcare provider about all of your medical conditions, including if you:

  • become sick very easily (have a weak immune system).

  • are pregnant or plan to become pregnant. It is not known if ZOVIRAX Cream will harm your unborn baby.

  • are breastfeeding or plan to breastfeed. It is not known if ZOVIRAX Cream passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use ZOVIRAX Cream.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use ZOVIRAX Cream?

  • Use ZOVIRAX Cream exactly as your healthcare provider tells you to use it.
  • Use ZOVIRAX Cream as soon as you have the first symptoms of a cold sore such as itching, redness, burning or tingling, or when the cold sore appears.
  • Wash your hands with soap and water before and after applying ZOVIRAX Cream.
  • The affected area should be clean and dry before applying ZOVIRAX Cream.
  • Apply ZOVIRAX Cream to the affected area 5 times each day for 4 days, including the outer edge.
  • You should not apply other skin products to the affected area during treatment with ZOVIRAX Cream.
  • Avoid unnecessary rubbing of the cold sore because this may cause the cold sore to spread to other areas around your mouth or make your cold sore worse.

What are the possible side effects of ZOVIRAX Cream?

The most common side effects of ZOVIRAX Cream are skin reactions at the treatment site and may include: dry or cracked lips, peeling, flaking or dryness of the skin, a burning or stinging feeling, and itching.

These are not all the possible side effects of ZOVIRAX Cream. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ZOVIRAX Cream?

  • Store ZOVIRAX Cream at room temperature between 68° to 77°F (20° to 25°C).

Keep ZOVIRAX Cream and all medicines out of reach of children.

General information about the safe and effective use of ZOVIRAX Cream.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ZOVIRAX Cream for a condition for which it was not prescribed. Do not give ZOVIRAX Cream to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about ZOVIRAX Cream that is written for health professionals.

What are the ingredients in ZOVIRAX Cream?

Active ingredient: acyclovir

Inactive ingredients: cetostearyl alcohol, mineral oil, poloxamer 407, propylene glycol, sodium lauryl sulfate, water, and white petrolatum

Distributed by: Bausch Health US, LLC

Bridgewater, NJ 08807 USA

Manufactured by: Bausch Health Companies Inc.

Laval, Quebec H7L 4A8, Canada

Zovirax is a trademark of GlaxoSmithKline LLC used under license.

© 2021 Bausch Health Companies Inc. or its affiliates

For more information, call 1-800-321-4576.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: 02/2021

9462203

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 021478 · View the label on DailyMed

Revision date stated in the text: February 2021

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Zovirax Topical Cream

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor, Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor, Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor
Active ingredient Acyclovir 50 mg/g
Dosage form Cream
Route Topical
Marketing status listed in the FDA NDC Directory
Company (applicant) BAUSCH
FDA approval NDA 021478New Drug Application (NDA) Approved December 30, 2002
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics Acyclovir Topical with the same TE code
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
50 mg/g – 5 g in 1 tube / 1 in 1 carton NDC 0187-0994-45
50 mg/g – 0.9 g in 1 tube / 1 in 1 carton NDC 0187-0994-20

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.