Benzalkonium Chloride; Benzocaine topical cream

What is this medication?

BENZALKONIUM CHLORIDE; BENZOCAINE (ben zal KOE nee um klor ide; BEN zoe kane) is a topical combination of an antiseptic and anesthetic. It is used to treat itching, burning, irritation, or infection affecting the skin around the vagina.

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

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)
• smoke tobacco cigarettes
• an unusual or allergic reaction to benzalkonium chloride, benzocaine, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is for external use only. Do not take by mouth. 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 at the same time every day. Do not use it more often than directed.

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

Talk to your health care provider about the use of this medicine in children. While it may be given to children as young as 12 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 medicine 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 are of skin without talking to your health care professional.

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

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 medicine and contact your health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reaction (skin rash, itching or hives; swelling of the face, lips, or tongue)
• methemoglobinemia (trouble breathing; fast, irregular heartbeat; feeling faint or lightheaded, falls; headache; pale, gray, or blue colored mouth, nails or skin; unusually weak or tired)

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

• burning, stinging of treated skin

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 medicine after the expiration date.

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

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, empty the medicine out of the container. Mix the medicine 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.