ZELSUVMI Topical gel Ref.[107468] Active ingredients: Berdazimer

2.1 Important Preparation and Administration Instructions

• ZELSUVMI is supplied in a carton containing the following:
  • Tube A containing berdazimer gel
  • Tube B containing hydrogel
  • Dosing guide
• Mix together equal amounts of gel from Tube A and Tube B before application <em<[see Dosage and Administration (2.2)].
• Do not premix or store mixed ZELSUVMI.
• Instruct the patient to refer to the ZELSUVMI “Instructions for Use” for detailed instructions on the preparation and administration of ZELSUVMI <em<[see Instructions for Use].

2.2 Recommended Dosage and Administration

• Dispense equal amounts (0.5 mL) of gel from Tube A and Tube B on the dosing guide. Immediately put the caps back on Tube A and Tube B tightly.
• Mix together on the dosing guide.
• Immediately apply ZELSUVMI as an even thin layer. Apply ZELSUVMI once daily to each MC lesion for up to 12 weeks.
• Wash hands after applying ZELSUVMI, unless hands are being treated.
• Allow ZELSUVMI to dry for 10 minutes after application.
• Avoid application to uninvolved skin and avoid transfer of applied ZELSUVMI to other areas, including the eye.
• Avoid swimming, bathing, or washing for 1 hour after application of ZELSUVMI.
• ZELSUVMI is for topical use only and not for ophthalmic, oral, or intravaginal use.

Prior to Dispensing: Store ZELSUVMI in a refrigerator between 2°C and 8°C (36°F and 46°F) until dispensed to the patient. Write the “Discard after” date in the space provided on the carton.

After Dispensing: Store ZELSUVMI at room temperature, between 20°C to 25°C (68°F and 77°F) in a dry location.

Product contains alcohol and should be kept away from open flame.

Do not freeze.

Discard 60 days after removal from refrigeration.