When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to any of its ingredients. You should not use Silvadene® cream if you have had an allergic reaction to silver sulfadiazine or other sulfa drugs. Do not use Silvadene® cream on babies less than 2 months old, or if you are pregnant and near or at term.

How to Use This Medicine:
Cream, Ointment, Lotion, Gel/Jelly, Swab, Spray, Foam, Sponge, Liquid

• This medicine should not be used in your eyes, inside your body, or over large areas of skin. If this medicine does get in your eyes, nose, or mouth, rinse it off right away.
• Wash your hands with soap and water before and after you use this medicine. Follow your doctor's instructions about how to clean and care for your wound while you are using this medicine.
• Follow the instructions on the medicine label if you are using this medicine without a prescription.
• Some forms of this medicine may contain alcohol. Do not use these medicines near a fire or if you are smoking.
• Different forms of this medicine are used in different ways. Be sure you understand all the directions before you use them. Ask a pharmacist if you have any questions.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are using cimetidine (Tagamet®), or a sulfa drug such as trimethoprim/sulfamethoxazole, Bactrim®, Cotrim®, or Septra®. Do not use any other medicines on the treated skin unless your doctor tells you to.
• Do not put cosmetics or skin care products on the treated skin.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breast feeding, or if you have kidney disease, liver disease, or any problems with your blood.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Call your doctor if your symptoms do not improve or if they get worse. Call your doctor if you are using Bactroban® and your skin does not get better in 3 to 5 days.
• In some cases, the long-term use of topical antibacterial medicines can cause a fungal infection. Tell your doctor if you notice new or increased pain, redness, or swelling on the treated skin.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash.
• Change in how much or how often you urinate.
• Dark-colored urine, blood in the urine, or pale stools.
• Nausea, vomiting, loss of appetite, or pain in your upper stomach.
• Redness, burning, itching, or swelling in the area where the medicine is applied.
• Unexplained fever, chills, cough, sore throat, and body aches.
• Unusual bleeding, bruising, or weakness.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Change in the color of your skin where the medicine is applied.
• Headache.
• Nausea.
• Skin dryness.
• Swelling in your hands, ankles, or feet.

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088