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Xerese: Uses, Side Effects and Dosage

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Facts
Status:
Prescription (Rx)
Strength:
50 mg/g, 10 mg/g
Drug class:
Active ingredients:
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Xerese

What is XERESE?

  • XERESE is a prescription medicine used in people 6 years of age and older to shorten the healing time of cold sores (herpes labialis) and lower the chance of a cold sore becoming worse (ulcerating).
  • XERESE is not a cure for cold sores.

It is not known if XERESE is safe and effective in children less than 6 years of age.

What should I tell my healthcare provider before using XERESE?

Before using XERESE, 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 XERESE will harm your unborn baby.

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

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 XERESE?

  • Use XERESE exactly as your healthcare provider tells you to use it.
  • Use XERESE as soon as you have the first symptom of a cold sore such as itching, redness, burning or tingling or when the cold sore appears.
  • Apply XERESE over the affected area, including the outer edge of the cold sore.
  • Do not rub the cold sore because this may cause the cold sore to spread to other areas around your mouth or make your cold sore worse.
  • Do not cover the cold sore or the area around the cold sore with a bandage.
  • Do not use other skin products (such as make-up, sun screen or lip balm) or other skin medicine on the cold sore or the area around the cold sore.
  • Tell your healthcare provider if your cold sore is not better in 2 weeks.

What are the possible side effects of XERESE?

The most common side effects of XERESE are skin reactions at the treatment site and may include:

  • drying or flaking, tingling or burning after you apply XERESE, redness, changes in skin color where the cream is applied, and swelling.

These are not all the possible side effects of XERESE. 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 XERESE?

  • Store XERESE at room temperature between 68° to 77°F (20° to 25°C). Do not freeze XERESE.

Keep XERESE and all medicines out of the reach of children.

General information about the safe and effective use of XERESE.

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

What are the ingredients in XERESE?

Active ingredients: acyclovir and hydrocortisone

Inactive ingredients: cetostearyl alcohol, citric acid monohydrate, isopropyl myristate, mineral oil, Poloxamer 188, propylene glycol, sodium lauryl sulfate, purified water, USP, sodium hydroxide, and white petrolatum. May also contain hydrochloric acid.

Distributed by: Bausch Health US, LLC, Bridgewater, NJ 08807 USA

Manufactured by: Bausch Health Companies Inc., Laval, Quebec H7L 4A8, Canada

Product under license from Meda Pharma S.A.R.L., Luxembourg by Bausch Health Ireland Limited, Dublin, Ireland

U.S. Patent Number: 7,223,387

XERESE is a trademark of Meda Pharma S.A.R.L. used under license.

Zovirax is a registered trademark of the GlaxoSmithKline group of companies.

© 2020 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: 08/2020

9587303

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 022436 · View the label on DailyMed

Revision date stated in the text: August 2020

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 Xerese

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Corticosteroid, Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor, Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor, Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor
Active ingredients Acyclovir 50 mg/g, Hydrocortisone 10 mg/g
Dosage form Cream
Route Topical
Marketing status listed in the FDA NDC Directory
Company (applicant) BAUSCH
FDA approval NDA 022436New Drug Application (NDA) Approved July 31, 2009
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
50 mg/g, 10 mg/g – 5 g in 1 tube / 1 in 1 carton NDC 0187-5104-01
50 mg/g, 10 mg/g – 0.5 g in 1 packet / 20 in 1 carton NDC 0187-5104-02

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.