Benzocaine; Zinc Chloride; Benzalkonium Chloride Oral Gel

What is this medication?

BENZOCAINE; ZINC CHLORIDE; BENZALKONIUM CHLORIDE (BEN zoe kane; zingk KLOOR ide; ben zal KOE nee um klor ide) treats and relieves minor pain in your mouth from canker or cold sores, fever blisters, and irritation. It works by numbing the affected area.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Orajel Mouth Sore

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Diabetes (high blood sugar)
• G6PD deficiency
• Heart disease
• High thyroid levels
• Liver disease
• Lung or breathing disease (asthma, COPD)
• Tobacco use
• An unusual or allergic reaction to benzalkonium chloride, benzocaine, zinc, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is for topical use only. Do not swallow. Wash your hands before and after use. Do not get it in your eyes. If you do, rinse your eyes with plenty of cool tap water. Use it as directed on the label. Do not use it more often than directed.

Apply a thin film of the medication to the affected area.

Talk to your care team about the use of this medication in children. While it may be given to children as young as 2 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply. This medication is not for regular use. It should only be used as needed.

What may interact with this medication?

Interactions are not expected. Do not use any other skin products on the same area of skin without talking to your care team.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. If you need to use this medication for more than 1 week, talk to your care team.

Be careful to avoid injury while the area is numb, and you are not aware of pain.

If you notice a blue or gray discoloration of the mouth, lips, or nail beds, stop taking this medication and contact your care team.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Headache, unusual weakness or fatigue, shortness of breath, nausea, vomiting, rapid heartbeat, blue skin or lips, which may be signs of methemoglobinemia

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Mild skin irritation, redness, or dryness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.