Lidocaine and prilocaine are local anesthetics (numbing medicines). They work by blocking nerve signals in your body.

VallaDerm-90 (for the skin) is a combination medicine used to numb the skin or surfaces of the penis or vagina. VallaDerm-90 is used to prepare you for minor surgery or medical procedures on these areas.

VallaDerm-90 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. Overdose symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

Use the smallest amount of VallaDerm-90 needed to numb the skin. Do not use large amounts of VallaDerm-90, or cover treated skin areas with a bandage or plastic wrap without medical advice.

Follow all directions on your prescription label. Do not apply VallaDerm-90 in larger amounts than recommended.

You may need to apply VallaDerm-90 at home up to 4 hours before your surgery or procedure. You will be given instructions about how much medicine to use and how long to leave it on the skin. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Use the smallest amount of medicine needed to numb the skin. 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.

You may need to cover the skin to help keep the medicine in place. Do not cover treated skin unless your doctor has told you to.

Carefully follow dosing instructions when applying this medicine to a child. VallaDerm-90 doses are based on weight in children. Do not allow a child to use this medicine without adult supervision.

Store at room temperature away from moisture and heat. Do not allow the cream to freeze.

You should not use VallaDerm-90 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.

To make sure VallaDerm-90 is safe for you, tell your doctor if you have:

• a blood cell disorder called methemoglobinemia;

• liver disease;

• a genetic enzyme deficiency called glucose-6-phosphate dehydrogenase (G6PD) deficiency; or

• a family history of methemoglobinemia, or any genetic enzyme deficiency.

FDA pregnancy category B. VallaDerm-90 is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Lidocaine and prilocaine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Call your doctor for instructions if you forget to apply VallaDerm-90 at the time needed before your surgery or medical procedure.

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

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

Do not allow VallaDerm-90 to come into contact with your eyes. If it does, rinse with water.

Do not take by mouth. VallaDerm-90 is for use only on the skin.

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 any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

VallaDerm-90 may cause serious side effects. Call your doctor at once if you have:

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

• swelling or redness;

• sudden dizziness or drowsiness after medicine is applied;

• confusion, blurred vision, ringing in your ears;

• bruising or purple appearance of the skin; or

• unusual sensations of temperature.

Common side effects of VallaDerm-90 may include:

• mild burning where the medicine is applied;

• itching, rash; or

• changes in skin color where the medicine was 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.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with VallaDerm-90, especially:

• chloroquine, dapsone, nitrofurantoin, isosorbide dinitrate, nitroglycerin, nitroprusside, quinine;

• heart rhythm medication--amiodarone, dofetilide, dronedarone, mexiletine, sotalol, tocainide, and others;

• seizure medicine--phenobarbital, phenytoin, primaquine; or

• a sulfa drug--Bactrim, Septra, SMX-TMP or SMZ-TMP, and others.

This list is not complete. Other drugs may interact with lidocaine and prilocaine topical, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.