Xylocaine Topical

Lidocaine is a local anesthetic (numbing medication). It works by blocking nerve signals in your body.

Lidocaine topical (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. Lidocaine topical is also used to treat rectal discomfort caused by hemorrhoids.

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

You should not use lidocaine topical 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 lidocaine topical is safe for you, tell your doctor if you have:

• liver disease; or

• if you take a heart rhythm medicine.

Lidocaine topical is not expected to harm an unborn baby. Tell your doctor if you are pregnant.

It is not known whether lidocaine topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Use this medicine 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.

Lidocaine topical comes in many different forms (gel, spray, cream, lotion, ointment, liquid, skin patch).

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

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.

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

If your medicine comes with patient instructions for safe and effective use, follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Store at room temperature away from moisture and heat.

Keep both used and unused lidocaine topical 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.

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.

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

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; 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.

Applies to lidocaine topical: topical application aerosol liquid, topical application cream, topical application dressing, topical application foam, topical application gel/jelly, topical application lotion, topical application ointment, topical application pad, topical application patch extended release, topical application powder, topical application solution, topical application spray

Along with its needed effects, lidocaine topical (the active ingredient contained in Xylocaine Topical) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking lidocaine topical:

• Blistering, crusting, irritation, itching, or reddening of the skin
• cough
• cracked, dry, or scaly skin
• fast heartbeat
• fever
• hives or welts, itching, or skin rash
• hoarseness
• irritation
• joint pain, stiffness, or swelling
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• noisy breathing
• swelling of the eyelids, face, lips, hands, or feet
• tightness in the chest
• troubled breathing or swallowing

• Blistering, bruising, burning, discoloration, itching, redness, or swelling at the application site
• blurred vision
• chest pain or discomfort
• cold, clammy, or pale skin
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness or dizziness
• false or unusual sense of well-being
• fear or nervousness
• irregular, fast or slow, or shallow breathing
• lethargy
• no blood pressure or pulse
• pale or blue lips, fingernails, or skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• seizures
• shakiness in the legs, arms, hands, or feet
• slow heart rate
• slow or irregular heartbeat
• stopping of heart
• trembling or shaking of the hands or feet
• twitching
• unconsciousness
• unusual tiredness or weakness
• weakness

Some side effects of lidocaine topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Bad, unusual, or unpleasant (after) taste
• change in taste
• cold or numbness
• confusion about identity, place, and time
• continuing ringing or buzzing or other unexplained noise in the ears
• double vision
• headache
• hearing loss
• heat sensation
• lack or loss of strength
• metallic taste
• sleepiness or unusual drowsiness