Berdazimer (ber-DAZ-i-mer)

Treats molluscum contagiosum (molluscum bumps).

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Gel/Jelly

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Use this medicine only on your skin. Rinse it off right away if it gets on a cut or scrape. Do not get the medicine in your eyes, nose, or mouth.
• Wash your hands with soap and water before and after you use this medicine.
• Apply a thin layer of the medicine to the affected area. Rub it in gently.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Zelsuvmi™ carton contains: 1 blue tube that contains berdazimer gel (tube A), 1 yellow tube that contains hydrogel (tube B), and 1 dosing guide.
• The gels in tube A and tube B must be mixed together on the dosing guide before applying to your skin. Do not mix the gels until you are ready to apply this medicine.
• Gel:
  • Remove the cap from tube A. Hold tube A near blue tube A dosing lane. Squeeze gel onto blue lane to cover entire area of the lane. The gel is white on the dosing guide. Screw cap back onto tube A.
  • Remove cap from tube B. Hold tube B near yellow tube B dosing lane. Squeeze gel onto yellow lane to cover entire area of the lane. The gel is clear to almost clear on the dosing guide. Screw cap back onto tube B.
  • Use a fingertip to combine the 2 gels from the blue and yellow lanes. Mix the gels in the center of the dosing guide using a circular motion. Mix the 2 gels together while slowly counting to 20. You may see clumps while mixing, which is normal. Apply an even thin layer of the mixed gel to each bump right away.
  • Make sure to cover bumps that are new, hard to reach, or out of sight.
  • If you run out of mixed gel before you have treated all the bumps, wipe off your dosing guide with a dry tissue and repeat the steps on mixing the gel.
  • Wait at least 10 minutes before putting clothes on the skin to allow the mixed gel to dry.
  • Wait at least 1 hour after applying gel before swimming, washing, bathing, or showering.
  • Use water and mild soap to remove the remaining gel from the dosing guide. Dry the dosing guide.
  • Make sure to put the blue cap onto the blue tube and put the yellow cap onto the yellow tube. If you mix the caps, wipe caps with dry tissue and replace caps on the correct tubes.
• Missed dose: Apply a dose as soon as you can. If it is almost time for your next dose, wait until then and apply a regular dose. Do not apply extra medicine to make up for a missed dose.
• Store this medicine in the refrigerator. Do not freeze. You may store mixed gel at room temperature in a dry location. This medicine contains alcohol and should be kept away from open flame.
• Throw away unused medicine within 60 days after receiving it.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding.
• Do not use this medicine to treat a skin problem your doctor has not examined.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Darkening or lightening of the skin
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Itching, burning, pain, peeling, flaking, redness, stinging, swelling, or skin irritation where the medicine is applied

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088