Berdazimer Gel

What is this medication?

BERDAZIMER (ber DAZ i mer) treats molluscum, a common viral skin infection that causes small, firm bumps on the skin. It will not treat infections caused by bacteria.

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

COMMON BRAND NAME(S): ZELSUVMI

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

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

• Other skin conditions
• An unusual or allergic reaction to berdazimer, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

This medication is for external use only. Do not take by mouth. Wash your hands before and after use. If you are treating your hands, only wash your hands before 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. Keep using it unless your care team tells you to stop.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

Mix together gels from Tube A and Tube B before you apply to your skin. Do not mix the gels until you are ready to apply this medication.

Apply a thin film of the medication to the affected area. Do not apply to burned or damaged skin. If you do, rinse the burned or damaged skin with water. Do not apply near your eyes, mouth, or vagina. Wait at least 10 minutes after applying before putting clothes on skin to allow the medication to dry. Wait at least 1 hour after applying before swimming, washing, bathing, or showering.

Talk to your care team about the use of this medication in children. While it may be given to children as young as 1 year 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?

If you miss a dose, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medication?

Interactions have not been studied. 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 you care team if your symptoms do not start to get better or if they get worse.

This medication is flammable. Avoid fire, flames, and smoking near the treated area.

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
• Burning, itching, crusting, or peeling of treated skin

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

• Change in skin color
• Irritation at application site

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). Do not freeze. Keep the containers tightly closed. Get rid of this medication 60 days after the prescription was filled, even if you have not used the medication yet.

This medication is flammable. Avoid exposure to heat, fire, flame, and smoking.

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, ask your pharmacist or care team how to get rid of this medication safely.

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.