Dent-O-Kain

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, teething pain, 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.

There are many brands and forms of benzocaine topical available and not all brands are listed on this leaflet.

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

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

An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This is more likely to occur when using a numbing medicine 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 it is safe for you to use this medicine if you have:

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

• heart disease;

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

• if you smoke.

It is not known whether benzocaine topical will harm an unborn baby. Ask a doctor before using this medicine if you are pregnant.

It is not known whether benzocaine topical passes into breast milk or if it could affect a nursing baby. Ask a doctor before using this medicine if you are breast-feeding.

Do not use this medicine on a child younger than 2 years old without medical advice.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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

Your body may absorb more 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 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.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

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.

To treat hemorrhoids, apply the medication up to 6 times per day.

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.

Try to empty your bowel and bladder just before using the benzocaine suppository.

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

For best results, stay lying down for a few minutes. The suppository will melt quickly and you should feel little or no discomfort while holding it in. Avoid using the bathroom for at least an hour after using the suppository.

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.

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).

Benzocaine topical used in the mouth or throat may cause a rare but life-threatening condition called methemoglobinemia. In this condition, the amount of oxygen in your blood stream becomes dangerously low. 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:

• headache, tired feeling, confusion;

• fast heart rate;

• 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.

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 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.

Applies to benzocaine topical: compounding powder, mucous membrane gel, mucous membrane liquid, mucous membrane lozenge, mucous membrane paste, mucous membrane powder for reconstitution, mucous membrane spray, mucous membrane swab, mucous membrane tablet disintegrating, rectal ointment, rectal suppository, topical cream, topical gel, topical liquid, topical lotion, topical ointment, topical spray, topical stick, topical swab

Dermatologic

Dermatologic side effects have included contact dermatitis and urticaria.[Ref]

Local

Local side effects have included burning and stinging.[Ref]

Other

Other side effects have included edema.[Ref]

Cardiovascular

Cardiovascular side effects have included angioedema.

Hematologic

Hematologic side effects have included methemoglobinemia. FDA continues to receive reports of methemoglobinemia from postmarketing reporting.[Ref]

Some side effects of Dent-O-Kain may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.