"Today, the U.S. Food and Drug Administration issued a proposed order that, if finalized, would reclassify sunlamp products and require labeling to include a recommendation designed to warn young people not to use these devices.
(acyclovir and hydrocortisone) Cream 5%/1%
Important information: XERESE is for use on cold sores on the lips and around the mouth only. XERESE should not be used in your eyes, mouth, nose or on your genitals.
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.
Tell your healthcare provider about all the medicines you take, including prescription and over-thecounter 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°F to 77°F (20°C 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 health professionals.
What are the ingredients in XERESE?
Active ingredients: acyclovir and hydrocortisone
Inactive ingredients: cetostearyl alcohol, mineral oil, Poloxamer 188, propylene glycol, isopropyl myristate, sodium lauryl sulfate, white petrolatum, citric acid, sodium hydroxide and water. May also contain hydrochloric acid.
Last reviewed on RxList: 2/3/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Xerese Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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