Orabase Paste contains benzocaine, a local anesthetic (numbing medication). It works by blocking nerve signals in your body.

Orabase Paste is used to numb the skin or surfaces inside the mouth.

Orabase Paste should not be used to treat teething pain in infants, and is not approved for use in a child younger than 2 years old.

Orabase used in the mouth may cause a condition in which the oxygen in the 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 this medicine 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 benzocaine can cause fatal side effects if too much benzocaine is absorbed through your skin or mouth and into your blood. Use the smallest amount needed.

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

Before taking this medicine

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

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

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

Your body may absorb more benzocaine if you use too much, if you apply Orabase Paste over large areas, or if you apply heat. Skin or membranes that are cut or irritated may also absorb more topical medication than healthy tissue.

Use the smallest amount needed to numb the area or to relieve pain. Do not use large amounts of benzocaine topical.

Do not use Orabase to treat large areas or deep puncture wounds. Avoid using the medicine on areas that are raw or blistered, such as burn areas or abrasions.

Call your doctor if your symptoms do not improve or if they get worse within the first 7 days of using Orabase Paste. 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 Orabase if you have ever had methemoglobinemia in the past.

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

Since Orabase 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 inside the mouth 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 Orabase on your gums or inside your mouth.

Orabase is for use only inside the mouth. Avoid getting this medication in your eyes. Avoid swallowing the paste while applying it to your gums or the inside of your mouth.

Benzocaine 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 Orabase 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 to Orabase Paste: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Orabase 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 Orabase side effects 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 applied to the skin or membranes is less 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.