Important Administration Instructions

• All healthcare professionals should receive instruction and training prior to preparation and administration of YCANTH.
• YCANTH is for topical use only.
• YCANTH is not for oral, mucosal, or ophthalmic use. Avoid contact with the treatment area, including oral contact, after YCANTH treatment. Do not apply YCANTH near the eyes [see Warnings and Precautions (5.1), Overdosage (10)].
• If YCANTH contacts any unintended surface, including healthy skin, immediately remove by wiping with a cotton swab or gauze. Avoid other topical products on treated areas until 24 hours after YCANTH treatment or until washing [see Warnings and Precautions (5.2)].
• Avoid fire, flame or smoking near lesion(s) during treatment [see Warnings and Precautions (5.3)].

Dosage and Administration Overview

• Regarding YCANTH dosage and administration:
  • Use nitrile or vinyl gloves and eye protection during preparation and administration.
  • Apply topically as a single application to cover each lesion. Use no more than two YCANTH applicators during a single treatment session.
  • Remove with soap and water 24 hours after treatment. Administer YCANTH every 3 weeks as needed.
  • Do not cover any treated lesions with bandages.
  • If severe blistering, severe pain, or other severe adverse reactions occur, remove YCANTH with soap and water prior to 24 hours after treatment [see Warnings and Precautions (5.2)].
• Regarding use of the YCANTH applicator and break tool:
  • Do not reuse the applicator. The applicator is for a single treatment session only.
  • Do not attempt to use a clogged applicator.
  • Do not cut or modify the applicator in any way; doing so could reduce dispensing control.
  • Do not remove the applicator cap prior to breaking the glass ampule.
  • If any damage or leaks are observed on the applicator, applicators should be discarded in a sharps container and handled in accordance with accepted medical practice and applicable law. The YCANTH Break Tool should be managed as solid waste and placed in plastic recycling containers or the general trash.

Dosage and Administration Instructions

Instructions for preparing the YCANTH Applicator and administering the YCANTH Solution are presented below.

YCANTH includes the following components [see How Supplied/Storage and Handling (16.1)]:

Outer Protective Tube
The YCANTH Applicator
The YCANTH Break Tool
Step 1. Put on Personal Protective Equipment (PPE) Put on gloves and eye protection.
Step 2. Remove the YCANTH Applicator from Outer Protective Tube Use pull ring to remove purple end cap out of white outer protective tube. DO NOT remove the applicator cap. Slide the YCANTH Applicator out of the outer protective tube.
Step 3. Remove the Paperboard Sleeve Completely remove the white paperboard sleeve so that the glass ampule is visible. DO NOT remove the applicator cap prior to breaking the glass ampule.
Step 4. Inspect for Damage Inspect the YCANTH Applicator for the following types of damage:
Broken glass ampule	Cut or cracked applicator tube	No damage (for reference)
If any damage is observed, dispose of the YCANTH applicators in a sharps container and handle in accordance with accepted medical practice and applicable law.
Step 5. Break Ampule using the YCANTH Break Tool Set the YCANTH Break Tool on a horizontal surface. Ensure the applicator cap is in place. Place the YCANTH Applicator in the YCANTH Break Tool with the cap pointing toward the hinge. Press down firmly on the YCANTH Break Tool until a snap is heard. Open the YCANTH Break Tool and remove the YCANTH Applicator. If any leaks are observed, applicators should be discarded in a sharps container and handled in accordance with accepted medical practice and applicable law.
Step 6. Tap YCANTH Applicator to move YCANTH Solution Gently tap the capped end of the YCANTH Applicator on a horizontal surface for approximately 10 seconds or until the YCANTH Solution has collected at the bottom of the applicator tube.
Step 7. Test the YCANTH Applicator Remove the applicator cap. Gently squeeze the applicator tube to apply a droplet to a paper towel or gauze to confirm the YCANTH Applicator is working properly.
Step 8. Apply the YCANTH Solution Apply a small droplet of the YCANTH Solution onto a molluscum lesion. Use the applicator tip to spread the solution to cover the entire lesion. Repeat the application until all lesions have been treated. If YCANTH Solution contacts any unintended surface, including healthy skin, immediately remove by wiping with a cotton swab or gauze. DO NOT attempt to use a clogged YCANTH Applicator.
Step 9. Allow YCANTH Solution to Dry Allow the YCANTH Solution to completely dry (up to 5 minutes) before contacting healthy skin to avoid transference. DO NOT cover any treated lesions with bandages.
Step 10. Dispose of the YCANTH Applicator Applicators should be discarded in a sharps container and handled in accordance with accepted medical practice and applicable law. DO NOT reuse the YCANTH Applicator.