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

How to Use This Medicine:
Gel/Jelly

• A dentist or other trained health professional will give you this medicine in an office or clinic setting. The medicine is applied to the gums using a special dispenser.

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 dentist knows if you are using acetaminophen, acetanilid, aniline dyes, benzocaine (Americaine®), chloroquine (Aralen®), dapsone, naphthalene, or gentian violet. Tell your dentist if you are also using mexiletine (Mexitil®), nitrofurantoin (Furadantin®, Macrobid®), nitroglycerin (Minitran®, Nitro-Bid®), nitroprusside (Nitropress®), pamaquine, para-aminosalicylic acid (Paser®), phenacetin, phenobarbital (Luminal®), phenytoin (Dilantin®), primaquine, quinine, a sulfonamide antibiotic (such as trimethoprim/sulfamethoxazole, Bactrim®), or tocainide (Tonocard®).

Warnings While Using This Medicine:

• Make sure your dentist knows if you are pregnant or breastfeeding, or if you have liver disease, heart disease, heart rhythm problems, or a blood disease called glucose-6-phosphate dehydrogenase (G6PD) deficiency.
• This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your dentist right away if you have a rash; itching; hoarseness; trouble with breathing; trouble with swallowing; or any swelling of your hands, face, or mouth after you receive the medicine.
• This medicine may cause a rare, but serious blood problem called methemoglobinemia. Call your dentist right away if you develop a blue or bluish purple color on the lips, fingernails, or skin, or have headaches, dizziness, fainting, sleepiness, or trouble with breathing after you receive this medicine.
• During the time that the gum feels numb, serious injury can occur. Be especially careful to avoid injury until the numbness wears off and you have normal feeling in the area. Avoid foods or liquids that are very hot or very cold. Do not chew gum or food while your mouth feels numb. You may accidentally bite your tongue or the inside of your cheeks.

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
• Dizziness or fainting.
• Fast, slow, pounding, or uneven heartbeat.
• Numbness in the mouth that continues.
• Pain, swelling, irritation, redness, sores, or blisters in the mouth.
• Skin, lips, or nailbeds turning pale gray or blue color.
• Tremors or convulsions (seizures).

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

• Change in taste.
• Fever, chills, cough, runny or stuffy nose, sore throat, and body aches.
• Headache.
• Muscle aches or joint pain.
• Nausea.
• Tiredness.

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