YCANTH

1 INDICATIONS AND USAGE YCANTH is indicated for the topical treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older. YCANTH is indicated for the topical treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older. ( 1 )

2 DOSAGE AND ADMINISTRATION All healthcare professionals should receive instruction and training prior to preparation and administration of YCANTH. ( 2.1 ) For topical use only. Not for oral, mucosal, or ophthalmic use. ( 2.1 ) Apply a single application directly to each lesion every 3 weeks as needed. ( 2.2 ) Do not use more than two applicators during a single treatment session. ( 2.2 ) Remove with soap and water 24 hours after treatment. ( 2.2 ) For additional instructions on preparation and administration of YCANTH, see Full Prescribing Information. ( 2.1 , 2.2 , 2.3 ) 2.1 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) ] . 2.2 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. 2.3 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 ca …

3 DOSAGE FORMS AND STRENGTHS Topical solution 0.7%: Each mL of YCANTH contains 7 mg (0.7%) of cantharidin in a light violet to dark purple, slightly viscous liquid. Topical solution: 0.7% cantharidin. ( 3 )

4 CONTRAINDICATIONS None None

6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling: Local Skin Reactions [see Warnings and Precautions (5.2) ] Most common (incidence ≥1%) adverse reactions are the following local skin reactions at the application site: vesiculation, pain, pruritus, scabbing, erythema, discoloration, application site dryness, edema, and erosion. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Verrica Pharmaceuticals Inc. at 1-877-837-7422 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Local skin reactions are expected and should be reported if they are severe. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. YCANTH was studied in two randomized, double-blind, placebo-controlled phase 3 trials, Trial 1 (NCT03377790) and Trial 2 (NCT03377803) (n = 266, and n = 262, respectively) in subjects with molluscum contagiosum. Most patients received a single 24-hour dermal administration of YCANTH or vehicle for each lesion every 3 weeks for up to 4 treatments. YCANTH Solution or vehicle were removed prior to the 24-hour timepoint in 109/311 (35%) subjects treated with YCANTH Solution and 46/216 (21%) subjects treated with vehicle due to treatment-emergent adverse events. Table 1 presents the percentage of subjects with selected adverse reactions (incidence ≥ 1%) by the most severe grade reported during Trial 1 and Trial 2. Adverse reactions were primarily local skin reactions at the application site. Local skin reactions at the application site were observed in 97% of subjects treated with YCANTH during both trials. Table 1. Percentage of Subjects with Selected Adverse Reactions (Incidence ≥1%) by Severity in Trial 1 and Trial 2 (Safety Population) YCANTH N=311 Vehicle N=216 Preferred Term Name Mild Moderate Severe Mild Moderate Severe Application site vesicles 60% 32% 4% 27% 2% 0% Application site pain and pain 41% 20% 2% 16% 1% 0% Application site pruritus and pruritus 47% 8% 1% 30% 7% 0% Application site scab and scab 39% 9% 0% 20% 1% 0% Application site erythema and erythema 24% 21% <1% 20% 7% 0% Application site discoloration 28% 4% <1% 12% 1% 0% Application site dryness 19% 2% 0% 14% 1% 0% Application site edema 7% 3% 0% 3% 1% 0% Application site erosion 6% 1% 0% 1% 0% 0% Contact dermatitis 0% 1% 0% 0% 0% 0% There were no serious adverse reactions reported in the two controlled trials. The discontinuation rate due to an adverse reaction was 2.3% among subjects treated with YCANTH and 0.5% among subjects treated with vehicle.

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no available data with use of YCANTH in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies were not conducted with cantharidin. Given that systemic exposure to cantharidin following topical administration is low, maternal use is not expected to result in fetal exposure to the drug [see Clinical Pharmacology (12.3) ]. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. 8.2 Lactation Risk Summary Avoid application of YCANTH topical solution to areas with increased risk for potential ingestion by or ocular exposure to the breastfeeding child. There are no data on the presence of cantharidin in either human or animal milk, or the effects on the breastfed infant or on milk production. Breastfeeding is not expected to result in exposure of the child to the drug due to the low systemic absorption of YCANTH following topical administration [see Clinical Pharmacology (12.3) ]. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for YCANTH topical solution and any potential adverse effects on the breastfeeding child from YCANTH topical solution or from the underlying maternal condition. 8.4 Pediatric Use Risk Summary The safety and effectiveness of YCANTH for the treatment of molluscum contagiosum have been established in pediatric patients aged 2 years and older. The use of YCANTH in pediatric patients is supported by results from adequate and well-controlled trials in patients 2 years of age and older; although the safety and efficacy of drug use for longer than 12 weeks has not been established [see Clinical Studies (14) ]. The safety and efficacy in pediatric patients below the age of 2 years have not been established . 8.5 Geriatric Use Risk Summary YCANTH has not been studied in geriatric patients.

12.1 Mechanism of Action The mechanism of action of cantharidin in the treatment of molluscum contagiosum is unknown.

11 DESCRIPTION YCANTH (cantharidin) topical solution is a light violet to dark purple, slightly viscous liquid for topical administration. Each mL of YCANTH topical solution contains 7 mg of active ingredient cantharidin (0.7%), a lipophilic compound. Cantharidin is a white to off-white solid at room temperature and is only very slightly soluble in water. The chemical name for cantharidin is 1,2-dimethyl-3,6-epoxyperhydrophthalic anhydride. The molecular weight is 196.20 g/mol and the molecular formula is C 10 H 12 O 4 . The structural formula for cantharidin is represented below: The inactive ingredients of YCANTH topical solution are acetone, camphor, castor oil, denatonium benzoate, ethanol (32%), gentian violet, hydroxypropyl cellulose, and nitrocellulose. The inactive ingredient denatonium benzoate is an oral deterrent to help mitigate the risk of accidental ingestion. Chemical Structure

10 OVERDOSAGE Oral ingestion of cantharidin has resulted in renal failure, blistering and severe damage to the gastrointestinal tract, coagulopathy, seizures, and flaccid paralysis. In the event that YCANTH topical solution is ingested, patients should seek medical attention immediately and contact a Poison Control Center (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.

16 HOW SUPPLIED/ STORAGE AND HANDLING 16.1 How Supplied YCANTH topical solution is supplied in a sealed glass ampule contained within a single-use applicator and enclosed in a protective paperboard sleeve. Each ampule of YCANTH contains approximately 0.45 mL of 0.7% cantharidin solution. Each mL of YCANTH contains 7 mg cantharidin (0.7%). A YCANTH Break Tool is co-packaged as 2 units per each 6 count and 12 count carton of applicators and 1 unit per each 1 count carton with 1 applicator. A listing of the available carton packages is provided in Table 3. Table 3. Available Carton Configurations for YCANTH Dosage Strength Single-Use Applicator Single Applicator NDC (Each) Number of YCANTH Applicators (Each) per Carton YCANTH Break Tool Part Reference Number Number of YCANTH Break Tools (Each) per Carton NDC 0.7% (7 mg/mL) 1 each 71349-070-01 1 71349-000-01 1 71349-070-11 6 71349-000-01 2 71349-070-06 12 71349-000-01 2 71349-070-12 Individual YCANTH Break Tools are available separately (Part Reference Number 71349-000-01). To request additional YCANTH Break Tools, contact Verrica Pharmaceuticals at 1-973-298-1390. 16.2 Storage and Handling Store at 20°C to 25°C (68° to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature], protect from light.