This medication contains 2 ingredients: acyclovir and hydrocortisone. It is used to treat cold sores/fever blisters caused by a virus (herpes simplex). Acyclovir is an antiviral medication that works by stopping the growth of the virus. Hydrocortisone is a corticosteroid that helps relieve itching, pain, and burning symptoms. This medication can speed up healing of cold sores, but it does not cure herpes or prevent passing the infection to someone else. It also does not prevent cold sores from returning.

Read the Patient Information Leaflet if available from your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Use this medication at the first sign of a cold sore. Wash your hands with soap and water before and after applying this medication. Clean and dry the affected area before applying the medication. Apply a thin layer on the affected area as directed by your doctor, usually 5 times a day (every 3 to 4 hours) for 5 days. Apply enough cream to cover all affected areas. Do not rub the area because it may spread to other areas around your mouth or make your cold sore worse. Do not apply other skin products (including make-up, sunscreen, or lip balm) or cover the affected area with a bandage. To prevent washing off the medication, do not bathe, shower, or swim for 30 minutes after application.

Do not apply this medication in the eyes or nose, inside the mouth, or on the genitals.

Cold sores (herpes) can spread easily. Acyclovir/hydrocortisone cream does not prevent the spread of herpes. Avoid sharing eating utensils, cups, razors, or towels during an outbreak. Also, try not to touch the cold sore (including kissing), and wash your hands if you do touch the cold sore.

Use this product regularly to get the most benefit from it. Tell your doctor if your condition lasts or gets worse after 2 weeks.

Dry/cracked lips, burning, stinging, redness, skin color changes, or dry/flaky skin may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using this product, tell your doctor or pharmacist if you are allergic to acyclovir or hydrocortisone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant before using this medication.

This product may pass into breast milk in small amounts. However, it is unlikely to harm a nursing infant. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others. Doing so may spread the infection.

Try to avoid or prevent conditions that stress your body and can trigger a cold sore outbreak, such as getting a cold or flu, not getting enough sleep, or staying in the sun without applying sunblock.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.