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

Benzocaine topical is used to reduce pain or discomfort caused by minor skin irritations, sore throat, sunburn, vaginal or rectal irritation, ingrown toenails, hemorrhoids, and many other sources of minor pain on a surface of the body. Benzocaine is also used to numb the skin or surfaces inside the mouth, nose, throat, vagina, or rectum to lessen the pain of inserting a medical instrument such as a tube or speculum.

Benzocaine topical should not be used to treat teething pain in infants, and is not approved for use in a child younger than 2 years old. There are many brands and forms of benzocaine topical available. Not all brands are listed on this leaflet.

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

Benzocaine topical used in the mouth may cause a condition in which the oxygen in your body tissues can become dangerously low. This is a potentially fatal condition called methemoglobinemia (met-HEEM-oh glo-bin-EE-mee-a). Do not use benzocaine topical if you have ever had methemoglobinemia.

GET EMERGENCY MEDICAL HELP IF YOU HAVE SYMPTOMS OF METHEMOGLOBINEMIA: headache, tired feeling, confusion, fast heart rate, and feeling light-headed or short of breath, with a pale, blue, or gray appearance of your skin, lips, or fingernails.

An overdose of numbing medication can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. Use the smallest amount needed.

Do not use benzocaine topical on a child younger than 2 years old.

Use exactly as directed on the label, or as prescribed by your doctor. Read all medication guides or instruction sheets.

Your body may absorb more of benzocaine topical 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.

Use the smallest amount needed to numb the skin or relieve pain. Do not use large amounts of benzocaine topical. Do not cover treated skin areas with a bandage or plastic wrap without medical advice.

Do not use benzocaine topical to treat large skin areas or deep puncture wounds. Avoid using the medicine on skin that is raw or blistered, such as a severe burn or abrasion.

To treat minor skin conditions, apply a thin layer of benzocaine topical to the affected area. If using the spray, hold the container 6 to 12 inches away from the skin. Do not spray this medication onto your face. Spray it instead on your hands and then rub it onto the face, avoiding contact with your eyes.

Clean the area with soap and water before applying benzocaine topical. Wash your hands before and after inserting a rectal suppository.

Do not take a rectal suppository by mouth. It is for use only in your rectum.

Remove the wrapper, but avoid handling the suppository too long or it will melt. Lie on your back with your knees up toward your chest. Gently insert the suppository into your rectum about 1 inch, pointed tip first.

Stay lying down for a few minutes while the suppository melts. You should feel little or no discomfort. Avoid using the bathroom for at least an hour.

Call your doctor if your symptoms do not improve or if they get worse within the first 7 days of using benzocaine topical. Also call your doctor if your symptoms had cleared up but then came back.

If you are treating a sore throat, call your doctor if the pain is severe or lasts longer than 2 days, especially if you also develop a fever, headache, skin rash, swelling, nausea, vomiting, cough, or breathing problems.

Store at room temperature away from moisture and heat. Do not freeze.

Do not use benzocaine topical if you have ever had methemoglobinemia in the past.

Do not use benzocaine topical on a child younger than 2 years old.

An overdose of numbing medication can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This can happen if you apply more than the recommended dose.

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

Ask a doctor or pharmacist if this medicine is safe to use if you have:

• a personal or family history of methemoglobinemia, or any genetic (inherited) enzyme deficiency;

• asthma, bronchitis, emphysema, or other breathing disorder;

• heart disease; or

• if you smoke.

Ask a doctor before using this medicine if you are pregnant or breast-feeding.

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

Since benzocaine topical 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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of benzocaine topical applied to the skin can cause life-threatening side effects such as uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

Avoid eating within 1 hour after using benzocaine topical on your gums or inside your mouth.

Benzocaine topical is for use only on the surface of your body, or just inside the mouth, vagina, or rectum. Avoid getting this medication in your eyes. Avoid swallowing the gel, liquid, or ointment while applying it to your gums or the inside of your mouth. The throat spray or oral lozenge may be swallowed gradually during use.

Benzocaine topical used in the mouth may cause a condition in which the oxygen in your body tissues can become dangerously low. This is a potentially fatal condition called methemoglobinemia (met-HEEM-oh glo-bin-EE-mee-a). This condition may occur after only one use of benzocaine or after several uses.

Signs and symptoms may occur within minutes or up to 2 hours after using benzocaine topical in the mouth or throat. GET EMERGENCY MEDICAL HELP IF YOU HAVE:

• a headache, tiredness, confusion;

• fast heartbeats;

• feeling light-headed or short of breath; and

• pale, blue, or gray appearance of your skin, lips, or fingernails.

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

Benzocaine topical may cause serious side effects. Stop using benzocaine topical and call your doctor at once if you have:

• severe burning, stinging, or sensitivity where the medicine is applied;

• swelling, warmth, or redness; or

• oozing, blistering, or any signs of infection.

Common side effects of benzocaine topical may include:

• mild stinging, burning, or itching where the medicine is applied;

• skin tenderness or redness; or

• dry white flakes 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.

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.