Pronunciation:

ber-DAZ-i-mer

Brand Names:

• Zelsuvmi

Uses of This Medicine:

Berdazimer topical gel is used to treat molluscum contagiosum (molluscum bumps).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of berdazimer topical gel in children younger than 1 year of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of berdazimer topical gel in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Skin problems—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine should come with a patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. If it does get on these areas, rinse it off right away with water.

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.

To use the gel:

• Wash your hands with soap and water before and after using this medicine.
• 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.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage form (gel):
  • For molluscum contagiosum:
    • Adults and children 1 year of age and older—Apply a thin layer to the affected area of the skin once a day for up to 12 weeks.
    • Children younger than 1 year of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

After mixing, you may store the 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.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits for any unwanted effects that may be caused by this medicine.

This medicine may cause serious allergic reactions, including dermatitis. Check with your doctor right away if you or you child have blistering, burning, crusting, dryness, or flaking of the skin or itching, scaling, severe redness, soreness, or swelling of the skin.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Flushing, pain, or redness of the skin at the application site

Less common

Discoloration, itching, swelling at the application site

fever

Rare

Body aches or pain

chills

cough

ear congestion

fever

headache

loss of voice

sneezing

stuffy or runny nose

unusual tiredness or weakness

vomiting

Incidence not known

Blistering, burning, crusting, dryness, flaking of the skin

itching, scaling, severe redness, soreness, swelling of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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