Special FDA Alert

In 2018, FDA requested the Drug Facts label for oral benzocaine products be updated to include:

1. Benzocaine oral drug products should not be used for teething.
2. Do not use benzocaine oral drug products in children under 2 years old.
3. Use of oral benzocaine products may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen in blood. This can occur even if you have used this product before.

Stop use and seek immediate medical attention if you or a child in your care develops:

• pale, gray, or blue colored skin (cyanosis)
• headache
• rapid heart rate
• shortness of breath
• dizziness or lightheadedness
• fatigue or lack of energy

Benzocaine is approved by the U.S. Food and Drug Administration (FDA) and is safe and effective when used according to the Drug Facts label

Safe use tips for throat and mouth pain medicines:

• You should not use lozenges to treat a sore throat for more than two days.
• You should not use a medicine to treat toothache pain for more than seven days.

Safe use tips for external vaginal itching and burning medicines:

• Do not apply vaginal medicines containing benzocaine to large areas of your body.

Safe use tips for hemorrhoid medicines:

• Hemorrhoid treatments containing benzocaine are intended to be used only on the outer surface of the lower rectum or anus. Do not put inside the rectum.

Safe use tips for skin irritation medicines:

• You should not use skin irritation medicines containing benzocaine over large areas of the body or in the eyes.

Ask a healthcare provider before use if:

For throat and mouth pain medicines:

• You have a personal or family history of methemoglobinemia, or any genetic (inherited) enzyme deficiency.
• You have asthma, bronchitis, emphysema, or other breathing disorder.
• You have heart disease.
• You smoke.
• You are pregnant or breast-feeding.

For external vaginal itching and burning medicines:

• Do not use for children under 12 years of age before consulting with a doctor.

For hemorrhoid medicines:

• Do not use for children under 12 years of age before consulting with a doctor.

Do not use if:

• You have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or any other “caine” anesthetics.
• Your condition worsens or does not improve within seven days.

For throat and mouth pain medicines:

• Do not use benzocaine oral drug products in children under 2 years old.
• Benzocaine oral drug products should not be used for teething. Fever and nasal congestion in infants are not symptoms of teething and could mean your baby has an infection. Contact a healthcare provider if your baby’s symptoms do not go away.
• Do not give an OTC throat lozenge containing benzocaine to a child under the age of 5.
• Children older than 2 years old should be supervised when using an oral discomfort treatment for toothache.

For hemorrhoid medicines:

• Rectal bleeding occurs while using a hemorrhoid treatment.

For skin irritation medicines:

• You have deep wounds, puncture wounds, an animal bite, or a serious burns

Stop use and ask a doctor if:

For throat and mouth pain medicines:

• Your sore throat has lasted for more than two days, is severe, or is accompanied by high fever, nausea, or vomiting.
• Your toothache does not improve within seven days, or if irritation, pain, or redness lasts or gets worse.
• You experience swelling of the mouth or a rash or fever develops.
• You take too much. Immediately contact a healthcare provider or the poison control national helpline at 800.222.1222.

For external vaginal itching and burning medicines:

• Conditions worsen.
• If symptoms persist for more than 7 days, or clear up and occur again within a few days.
• Topical vaginal medicines containing benzocaine are for external use only. If swallowed, immediately contact your healthcare provider or the poison control national helpline at 800.222.1222.

For hemorrhoid medicines:

• Conditions worsen or do not improve in 7 days.
• Bleeding occurs.
• Symptoms do not get better, or if redness, irritation, swelling, pain, or other symptoms occur or increase.
• Hemorrhoid medicines containing benzocaine are for external use only. If swallowed, immediately contact your healthcare provider or the poison control national helpline at 800.222.1222.

For skin irritation medicines:

• Conditions worsen or do not improve in 7 days.
• If swallowed, immediately contact your healthcare provider or the poison control national helpline at 800.222.1222.

What are the side effects of benzocaine?

• Use of oral benzocaine products may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:
• pale, gray, or blue colored skin (cyanosis)
• headache
• rapid heart rate
• shortness of breath
• dizziness or lightheadedness
• fatigue or lack of energy

Certain people may develop an allergic reaction to the active ingredient benzocaine. Get emergency medical help if you have difficulty breathing or swelling of your face, lips, tongue, or throat. Contact your healthcare provider or the poison control national helpline at 800.222.1222.