RealHeal-I

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

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

RealHeal-I may also be used for purposes not listed in this medication guide.

An overdose of numbing medicine can lead to serious side effects that may be fatal if too much medicine is absorbed through your skin. Symptoms of an overdose may include uneven heartbeats, seizures (convulsions), coma, slowed breathing, or respiratory failure (when breathing stops).

Use only the smallest amount of RealHeal-I necessary to numb the skin. Do not use large amounts of RealHeal-I, and do not cover treated skin areas with a bandage or plastic wrap without medical advice.

You should not use RealHeal-I if you are allergic to any numbing medicine.

Fatal overdoses have happened when numbing medicines were used without a doctor's advice (for example, during cosmetic procedures like laser hair removal). Overdose has also occurred in women who received a numbing medicine before having a mammography.

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

To ensure RealHeal-I is safe for you, inform your doctor if you have:

• a blood cell disorder called methemoglobinemia;
• liver disease;
• a genetic enzyme deficiency known as glucose-6-phosphate dehydrogenase (G6PD) deficiency; or
• a family history of methemoglobinemia, or any genetic enzyme deficiency.

FDA pregnancy category B. RealHeal-I is not expected to harm an unborn baby. Let your doctor know 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. Inform your doctor if you are breast-feeding a baby.

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.

RealHeal-I may cause serious side effects. Call your doctor right away if you have:

• severe burning, stinging, or irritation where the medicine was applied;
• swelling or redness;
• sudden dizziness or drowsiness after the medicine is applied;
• confusion, blurred vision, ringing in your ears;
• bruising or a purple appearance of the skin; or
• unusual sensations of temperature.

Common side effects of RealHeal-I 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.

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

You may need to apply RealHeal-I 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. RealHeal-I 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.

Call your doctor for instructions if you forget to apply RealHeal-I at the right time 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 serious side effects if too much of the medicine gets 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 use more than the recommended dose.

Do not let RealHeal-I come into contact with your eyes. If it does, rinse with water.

Do not take by mouth. RealHeal-I is meant for use only on the skin.

Be careful not to accidentally injure the treated skin areas while they are numb. Avoid touching very hot or very cold surfaces.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with RealHeal-I, 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.