When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to lidocaine, prilocaine, or other similar anesthetics such as bupivacaine, mepivacaine, or dibucaine.

How to Use This Medicine:
Cream, Thin Sheet

• A nurse or other trained health professional will give you this medicine. The medicine is usually applied right before the medical procedure in a hospital or clinic.
• You may be taught how to apply this medicine to yourself or your child at home before the medical procedure.
• Your doctor will tell you how much medicine to use. Do not use more than directed. Do not use it for any other condition without first checking with your doctor. This medicine may cause unwanted effects if too much is used, because more of it is absorbed through the skin.
• Use this medicine only on your skin. Rinse it off right away if it gets on a cut or scrape. Do not get the medicine in your eyes, nose, or mouth.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Wash your hands with soap and water before and after you use this medicine.
• Apply a thick layer of medicine to the area where numbness is needed. Do not spread the medicine on the skin.
• Cover the medicine with a special bandage called an occlusive dressing. This will keep the medicine in place. Your doctor will give you the bandage or tell you what to use.
• Seal the edges of the bandage to keep the medicine from leaking. Do not lift the bandage or disturb it. Keeping the medicine tightly covered helps it work properly.
• For babies or young children, a second covering may be used to prevent them from touching the medicine.
• Carefully watch your baby or child while the medicine is in place. Do not let them loosen or remove the bandage, touch the medicine, or put it in the mouth, eyes, nose, or ears.
• Keep the bandage in place until you or your child arrive at the hospital or clinic.
• Your doctor will remove the bandage and wipe the medicine off the skin before the medical procedure.

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 also using acetaminophen, acetanilid, aniline dyes, benzocaine (Americaine®), chloroquine (Aralen®), dapsone, or naphthalene. Tell your doctor if you are also using nitrofurantoin (Furandantin®), nitroglycerin (Nitrostat®), nitroprusside (Nitropress®), pamaquine, para-aminosalicylic acid, phenacetin, phenobarbital (Luminal®), phenytoin (Dilantin®), primaquine, quinine, or a sulfonamide antibiotic (such as trimethoprim/sulfamethoxazole, Bactrim®).
• Tell your doctor if you are also using a medicine to treat an abnormal heart rhythm such as amiodarone (Cordarone®), bretylium (Bretylol®), dofetilide (Tikosyn®), flecainide (Tambocor®), mexiletine (Mexitil®), propafenone (Rythmol®), quinidine (Cardioquin®, Quinaglute®, Quinidex®), sotalol (Betapace®), or tocainide (Tonocard®).

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you or your child have liver disease, heart disease, heart rhythm problems, methemoglobinemia (blood disease), or glucose-6-phosphate dehydrogenase (G6PD) deficiency (blood disease).
• Do not use this medicine on a baby younger than 3 months of age unless your child's doctor tells you to. Young babies may have more unwanted effects if too much is used and absorbed through the skin. If you use this medicine on a baby younger than 3 months of age, blood tests may be needed to check for unwanted effects.
• Do not use this medicine to treat a skin problem your doctor has not examined.
• During the time that the skin feels numb, serious injury can occur. Be especially careful to avoid injury until the numbness wears off and you or your child have normal feeling in the area. Do not scratch or rub the area, and do not allow very hot or very cold objects to touch it.
• Using too much of this medicine or using it on a large area of your skin can cause serious unwanted effects. Remove the cream and contact your doctor right away if you or your child have any of these symptoms: lightheadedness, dizziness, vision problems, an irregular or slow heartbeat, difficulty with breathing, or convulsions.
• This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash; itching; hoarseness; trouble with breathing; trouble with swallowing; or any swelling of the hands, face, or mouth after you receive the medicine.
• This medicine may cause a rare, but serious blood problem called methemoglobinemia. Remove the cream and call your doctor right away if you or your child develop a blue or bluish purple color on the lips, fingernails, or skin, or have headaches, dizziness, fainting, sleepiness, or trouble with breathing.

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
• Confusion, dizziness, sleepiness, or lightheadedness.
• Loss of color in your face or lips.
• Skin turns a blue color around your mouth, fingers, or toes.
• Tremors or convulsions (seizures).

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

• Mild burning, itching, or rash.
• Pale or red skin where the medicine was applied.
• Swelling of the skin where the medicine was applied.

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