Acyclovir is an antiviral medicine. Hydrocortisone is a steroid.

Acyclovir and hydrocortisone topical (for the skin) is a combination medicine that is used to treat cold sores in adults and children at least 6 years old.

acyclovir and hydrocortisone topical will not cure or prevent cold sores caused by herpes, but it can lessen the symptoms of the infection.

Acyclovir and hydrocortisone topical is for use for cold sores on the lips and around the mouth. This medication will not treat herpes lesions that affect the genitals or the eyes.

Acyclovir and hydrocortisone topical may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Start using acyclovir and hydrocortisone topical as soon as possible after the first appearance of symptoms (such as tingling, burning, itching, or redness). Acyclovir and hydrocortisone topical may not be effective if taken after you already have symptoms.

Wash your hands before and after applying the medicine. Also wash the skin area to be treated.

Apply a thin layer of acyclovir and hydrocortisone topical cream to cover the cold sore or tingly area. Do not rub the cold sore, to avoid making it worse or spreading the virus to other areas of your mouth.

Do not cover the treated skin with a bandage. Do not apply sunscreen, lip balm, or cosmetics to the treated cold sore area.

Acyclovir and hydrocortisone topical is usually applied 5 times per day for 5 days in a row. Follow your doctor's dosing instructions very carefully.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve.

Call your doctor if your symptoms do not improve after 2 weeks.

Store at room temperature away from moisture and heat. Do not freeze.

Usual Adult Dose for Herpes Simplex Labialis:

Apply a quantity sufficient to the affected area 5 times a day for 5 days

Comments:
-Initiate therapy as early as possible after the first signs/symptoms (i.e., during the prodrome or when lesions appear).
-Each dose should be applied to sufficiently cover the affected area, including the outer margin.

Use: For the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time

Usual Pediatric Dose for Herpes Simplex Labialis:

6 years or older: Apply a quantity sufficient to the affected area 5 times a day for 5 days

Comments:
-Initiate therapy as early as possible after the first signs/symptoms (i.e., during the prodrome or when lesions appear).
-Each dose should be applied to sufficiently cover the affected area, including the outer margin.

Use: For the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time

Tell your doctor if you have ever had a weak immune system (caused by disease by or using certain medicines).

Tell your doctor if you are pregnant or breastfeeding.

Acyclovir and hydrocortisone topical is not approved for use by anyone younger than 6 years old.

Apply the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not apply two doses at one time.

An overdose of acyclovir and hydrocortisone topical is unlikely to occur.

Avoid letting infected areas come into contact with other people. Avoid touching an infected area and then touching your eyes. Wash your hands frequently to prevent the spread of infection.

Do not share acyclovir and hydrocortisone topical with another person, even if they have the same symptoms you have.

Avoid getting this medicine in your eyes, nose, mouth, or vagina.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have severe burning, stinging, or irritation of treated skin.

Common side effects of acyclovir and hydrocortisone topical may include:

• mild burning or tingling after applying the medicine;

• skin dryness or flaking;

• swelling; or

• skin redness or discoloration.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Medicine used on the skin is not likely to be affected by other drugs you use. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.