Lidocaine is a local anesthetic (numbing medication). There are many brands and forms of lidocaine available. Not all brands are listed on this leaflet.

AneCream (for use on the skin) is used to reduce pain or discomfort caused by skin irritations such as sunburn, insect bites, poison ivy, poison oak, poison sumac, and minor cuts, scratches, or burns. This medicine is also used to treat rectal discomfort caused by hemorrhoids.

Lidocaine intradermal device can be used in minor medical procedures such as venipuncture or peripheral intravenous cannulation.

AneCream may also be used for purposes not listed in this medication guide.

An overdose of numbing medicine can cause fatal side effects if too much of the medicine is absorbed through your skin.

Do not use large amounts of lidocaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice.

Keep both used and unused lidocaine skin patches out of the reach of children or pets. The amount of lidocaine in the skin patches could be harmful to a child or pet who accidentally sucks on or swallows the patch.

Use AneCream exactly as directed on the label, or as it has been prescribed by your doctor. Do not apply this medicine in larger amounts than recommended.

Improper use of lidocaine topical may result in death.

AneCream comes in many different forms (gel, spray, cream, lotion, ointment, liquid, skin patch, and others).

Do not take by mouth. Topical medicine is for use only on the skin. If this medicine gets in your eyes, nose, mouth, rectum, or vagina, rinse with water.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Use the smallest amount of medicine needed to numb the skin or relieve pain. Your body may absorb too much of this medicine if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

Do not apply this medicine to swollen skin areas or deep puncture wounds. Avoid using the medicine on skin that is raw or blistered, such as a severe burn or abrasion.

Do not cover treated skin unless your doctor has told you to.

AneCream may be applied with your finger tips or a cotton swab.

Lidocaine intradermal device is applied by a healthcare provider.

Store at room temperature away from moisture and heat.

Keep both used and unused AneCream skin patches out of the reach of children or pets. The amount of lidocaine in the skin patches could be harmful to a child or pet who accidentally sucks on or swallows the patch. Seek emergency medical attention if this happens.

You should not use AneCream if you are allergic to any type of numbing medicine.

Fatal overdoses have occurred when numbing medicines were used without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). However, overdose has also occurred in women treated with a numbing medicine before having a mammography.

Be aware that many cosmetic procedures are performed without a medical doctor present.

Tell your doctor if you have ever had:

• a blood cell disorder called methemoglobinemia (in you or a family member);

• liver disease; or

• if you take a heart rhythm medicine.

Tell your doctor if you are pregnant or breastfeeding.

If you apply AneCream to your chest, avoid areas that may come into contact with the baby's mouth.

Since AneCream is used when needed, you may not be on a dosing schedule. Skip any missed dose if it's almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of numbing medicine can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood.

Overdose symptoms may include uneven heartbeats, seizure (convulsions), slowed breathing, coma, or respiratory failure (breathing stops).

Lidocaine applied to the skin is not likely to cause an overdose unless you apply more than the recommended dose.

Avoid touching the sticky side of a lidocaine skin patch while applying it.

Avoid accidentally injuring treated skin areas while they are numb. Avoid coming into contact with very hot or very cold surfaces.

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

AneCream may cause serious side effects. Call your doctor at once if you have:

• severe headache or vomiting;

• severe burning, stinging, or irritation where the medicine was applied;

• swelling or redness;

• sudden dizziness or drowsiness after medicine is applied;

• confusion, problems with speech or vision, ringing in your ears; or

• unusual sensations of temperature.

Common side effects include:

• mild irritation where the medication is applied; or

• numbness in places where the medicine is accidentally applied.

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 health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.