This Patient Information has been approved by the U.S. Food and Drug Administration.
Revised: January 2022
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PATIENT INFORMATION
Acyclovir (ay sye' kloe vir) Cream

Important information: Acyclovir cream is for use on cold sores on the lips and around the mouth only.
Acyclovir cream should not be used in your eyes, mouth, nose, or on your genitals.

What is acyclovir cream?

Acyclovir 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.
Acyclovir cream is not a cure for cold sores.

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

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

What should I tell my healthcare provider before using acyclovir cream?

Before using acyclovir 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 acyclovir cream will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if acyclovir cream passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use acyclovir 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 acyclovir cream?

Use acyclovir cream exactly as your healthcare provider tells you to use it.
Use acyclovir 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 acyclovir cream.
The affected area should be clean and dry before applying acyclovir cream.
Apply acyclovir 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 acyclovir 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 acyclovir cream?

The most common side effects of acyclovir 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 acyclovir 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 acyclovir cream?

Store acyclovir cream at room temperature between 68°F to 77°F (20°C to 25°C).

Keep acyclovir cream and all medicines out of the reach of children.

General information about the safe and effective use of acyclovir cream

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use acyclovir cream for a condition for which it was not prescribed. Do not give acyclovir 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 acyclovir cream that is written for health professionals.

What are the ingredients in acyclovir cream?
Active ingredient:acyclovir
Inactive ingredients:cetostearyl alcohol, mineral oil, poloxamer 407, propylene glycol, sodium lauryl sulfate, water, and white petrolatum

Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1
Dist. by: Taro Pharmaceuticals U.S.A., Inc.,Hawthorne, NY 10532
For more information, call 1-866-923-4914.

acyclovir

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