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YCANTH Cantharidin 3.2 mg/.45mL Solution, 1 applicator

by Verrica Pharmaceuticals Inc. · 1 APPLICATOR in 1 PACKAGE (71349-070-01) / 1 AMPULE in 1 APPLICATOR / .45 mL in 1 AMPULE

NDC 71349-0070-01

🏷️ FDA NDC (as labeled) 71349-070-01 billing pads the product segment with a zero

This package

Contains1 applicator Medicaid pays$1,444.53 / unit · 12 mo Per package$650.04 / 0.45 ml · Medicaid Pack sizes4 compare ↓

Also comes in: 1 applicator 71349-0070-06 1 applicator 71349-0070-12 1 applicator 71349-0070-11

Rx only Brand On market Non-controlled

🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 71349-070-01

Product NDC 71349-070

11-digit billing NDC 71349007001

NCPDP billing unit EA — each (per item)

RxCUI 244521, 2643442

UNII IGL471WQ8P

Application # NDA212905

SPL Set ID 7c9bdeaa-9822-4c69-a719-ea4a8643f59c

DEA schedule Non-controlled

Marketing category NDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2023-07-21

Route TOPICAL

Dosage form SOLUTION

Substance CANTHARIDIN

GPI-14 90750010002007

GCN Seq No 085085

GCN 54524

HICL code 002578

Ingredient (HICL) Cantharidin

HIC1 code L

Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue

HIC2 code L6

Therapeutic class — intermediate (HIC2) Irritants

HIC3 code L6A

Therapeutic class — specific (HIC3) Irritants/Counter-Irritants

AHFS code 84:04.06.00

AHFS class Antivirals (Skin And Mucous Membrane)

FDB label name YCANTH 0.7% SOLUTION

FDB brand name Ycanth

Legend status F — Federal legend — prescription drug or device

Why two NDCs? The FDA registers this code as 71349-070-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 71349-0070-01. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerVerrica Pharmaceuticals Inc.

Application holderVERRICA PHARMACEUTICALS INC

FDA applicationNDA212905 (NDA)

Labeler code71349

First marketedJul 2023

Product typeHuman Prescription Drug

Portfolio2 products on file

🔎 All NDCs from Verrica Pharmaceuticals Inc.

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name YCANTH 0.7% SOLUTION Ingredient Cantharidin

📖 What it is MedlinePlus · NLM

Cantharidin is used to treat molluscum contagiosum (molluscum bumps; a viral skin infection that causes raised, pearl-like bumps on the skin) in adults and children 2 years of age and older. Cantharidin is in a class of medications called vesicants. It is not known exactly how cantharidin works to treat molluscum contagiosum.

Read the full MedlinePlus article ↗

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Cantharidin — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor

🌿 Every supplement checked against Cantharidin (3 interactions) — ranked by severity →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.

Where does this data come from?

Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per mL	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	$1,444.53	$650.04 / 0.45 ml
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Ycanth 3.2 mg/.45mLthis 71349-0070-01	Verrica	1 applicator	—	—	FDA listed	—
Ycanth 3.2 mg/.45mL 71349-0999-01	Verrica	1 applicator	—	—	FDA listed	—

About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2023

First FDA approval

Jul 2023

📍

2026

Currently FDA-listed

3 years listed

🛡️

2041

Latest patent/protection listed

not a guaranteed launch date

🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Feb 2041. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.

📅 FDA approved Jul 21, 2023 RLD RS ⏳ ~14.4 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book

US 12233042 — method of use (U-3663)

US 11147790 — method of use (U-3663)

US 11147790 — method of use (U-3664)

US 11052064 — method of use (U-3665)

US 11052064 — method of use (U-3663)

US 12290651 — drug product

Exclusivity NCE

2023 2025 2027 2029 2031 2033 2035 2037 2039 2041

Today

LOE

Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo

🏛️FDA exclusivity

FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.

🧪Product / substance patents

Patents covering the active ingredient, product, formulation, or related drug features.

🎯Method-of-use patents

Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.

🛈 What do these terms mean?

Patent: Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent: Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent: Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent: A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label: A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity: FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV: A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS: Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating: FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity): The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (6)

Patent	Type	Use code	Expires
US 12233042 ↗	Method of use	U-3663	Aug 22, 2038
US 11147790 ↗	Method of use	U-3663	Aug 22, 2038
US 11147790 ↗	Method of use	U-3664	Aug 22, 2038
US 11052064 ↗	Method of use	U-3665	May 28, 2035
US 11052064 ↗	Method of use	U-3663	May 28, 2035
US 12290651 ↗	Drug product	—	Feb 19, 2041

FDA exclusivity

Code	What it grants	Expires
NCE	New Chemical Entity (5-year)	Jul 21, 2028

Common questions

Is there a generic version of YCANTH 0.7% SOLUTION?

No FDA-approved generic equivalent is currently listed in the FDA Orange Book for YCANTH 0.7% SOLUTION. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Feb 2041 — an estimate, not a guaranteed launch date.

The FDA approved a generic — why can’t I get it at my pharmacy yet?

FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.

Why do different websites show different generic release dates?

Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.

What does “FDA listed” mean?

It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.

What does a patent or protection date mean here?

It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).

What does “current Orange Book estimate” mean?

It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.

Can a generic come out before the last patent expires?

Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.

Can a generic come out after the listed dates?

Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.

What is the difference between patents and exclusivity?

Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.

Why are there multiple patent dates?

One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.

Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 71349-0070-01, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q4 2025 · 4 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

2.6K

Units reimbursed last 4 qtrs

1.9K

Gross reimbursed last 4 qtrs

$2.7M

Avg / prescription

$1,029.68

Avg / unit

$1,444.53

Latest quarter Q4 2025

621Rx

Fee-for-service vs managed care ⓘ

19% FFS 81% MCO

Fee-for-service · 486 Rx Managed care · 2,136 Rx

State Medicaid map

Units reimbursed · per 100k residents

0.08.9

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 Louisiana 8.9 /100k

2 Connecticut 4.7 /100k

3 Alabama 4.3 /100k

4 Nebraska 3.7 /100k

5 Kentucky 2.2 /100k

6 Florida 2.1 /100k

7 Ohio 1.0 /100k

8 Georgia 0.7 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

1 applicator this page71349-0070-01 2,622 Rx · $2,699,828

1 applicator71349-0070-06 858 Rx · $827,959

1 applicator71349-0070-11 33 Rx · $27,614

1 applicator71349-0070-12 No Medicaid data

Drug total (last 4 qtrs): 3,513 Rx · 2,444 units · $3,555,401 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)

Medicare Part D (outpatient prescription) spending for Ycanth — the program that covers self-administered drugs. 1 manufacturer.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Ycanth. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Total Part D spend

$32.6K

Claims incl. refills

Beneficiaries

Spend / beneficiary

$1,810.68

Spend / claim

$958.60

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for YCANTH (this brand).

Top reported reactions

Application Site Vesicles69

Application Site Pain47

Blister30

Pain14

Application Site Burn8

Application Site Erythema6

Blister Rupture6

Age at onset

Child5

Reporter sex

Male · 46%

Female · 54%

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
71349-0070-01 You're viewing this	1 APPLICATOR in 1 PACKAGE (71349-070-01) / 1 AMPULE in 1 APPLICATOR / .45 mL in 1 AMPULE	2023-07-21	Active
71349-0070-06	6 PACKAGE in 1 CARTON (71349-070-06) / 1 APPLICATOR in 1 PACKAGE (71349-070-01) / 1 AMPULE in 1 APPLICATOR / .45 mL in 1 AMPULE	2023-07-21	Active
71349-0070-12	12 CARTON in 1 CARTON (71349-070-12) / 6 PACKAGE in 1 CARTON (71349-070-06) / 1 APPLICATOR in 1 PACKAGE (71349-070-01) / 1 AMPULE in 1 APPLICATOR / .45 mL in 1 AMPULE	2023-07-21	Active
71349-0070-11	1 PACKAGE in 1 CARTON (71349-070-11) / 1 APPLICATOR in 1 PACKAGE (71349-070-01) / 1 AMPULE in 1 APPLICATOR / .45 mL in 1 AMPULE	2023-07-21	Active

In Medicaid, this is the most-dispensed pack of this product — about 75% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 71349-0070-01?

NDC 71349-0070-01 contains 1 applicator — 1 applicator in 1 package / 1 ampule in 1 applicator / .45 ml in 1 ampule.

What is the difference between NDC 71349-0070-01 and NDC 71349-0070-11?

Both are YCANTH Cantharidin 3.2 mg/.45mL Solution — the drug itself is identical. NDC 71349-0070-01 is the 1 applicator package, while NDC 71349-0070-11 is the 1 applicator package.

What NDC number is used to bill for this package of YCANTH Cantharidin 3.2 mg/.45mL Solution?

Bill NDC 71349-0070-01 — the 11-digit billing format is 71349007001. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	✓ Available
Inactive ingredients (structured)	— Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	✓ Available
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	✓ Available

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 71349-070-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 71349-0070-01, written without dashes as 71349007001. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 71349-0070-01, the first segment (71349) is the labeler code FDA assigned to Verrica Pharmaceuticals Inc.; the middle segment (0070) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Verrica Pharmaceuticals Inc.. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 3 other package presentations of this same product, including 1 applicator (71349-0070-06), 1 applicator (71349-0070-12), 1 applicator (71349-0070-11). Each has its own NDC and its own page — see the package list near the top of this page.

Who lists this product with the FDA?

Verrica Pharmaceuticals Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage 49 words ▾

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 )

⏱️ Dosage and Administration ~3 min read ▾

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 )

2.1Important 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) ] .

2.2Dosage 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.

2.3Dosage 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…

💊 Dosage Forms and Strengths 35 words ▾

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 )

⛔ Contraindications 4 words ▾

4 CONTRAINDICATIONS None None

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Toxicities Associated with Inappropriate Administration: Life threatening or fatal toxicities can occur if administered orally. Avoid contact with the treatment area, including oral contact, after treatment. Ocular toxicity can occur if YCANTH comes in contact with eyes.

If YCANTH gets in eyes, flush eyes with water for at least 15 minutes. ( 5.1 ) Local Skin Reactions : Reactions at the application site have included vesiculation, pruritus, pain, discoloration, and erythema. Avoid application near eyes and mucosal tissue, and to healthy skin.

If YCANTH contacts any unintended surface, or healthy skin, immediately remove. If severe local skin reactions occur, remove prior to 24 hours after treatment. ( 5.2 ) Flammability : YCANTH is flammable, even after drying.

Avoid fire, flame or smoking near lesion(s) during treatment and after application until removed. ( 5.3 )

5.1Toxicities Associated with Inappropriate Administration YCANTH is for topical use only. YCANTH is not for oral, mucosal, or ophthalmic use. Life threatening or fatal toxicities can occur if YCANTH is administered orally [see Overdosage (10) ].

Adverse reactions to oral ingestion of cantharidin have included renal failure, blistering and severe damage to the gastrointestinal tract, coagulopathy, seizures, and flaccid paralysis. Advise patients and/or caregivers to avoid oral contact and to avoid touching lesions after YCANTH treatment and to seek medical attention immediately if YCANTH is accidently ingested. Ocular toxicity can occur if YCANTH comes in contact with the eyes.

Adverse reactions from contact of YCANTH with the eyes can include corneal necrosis, ocular perforation, and deep ocular injuries. Do not apply YCANTH near or to the eyes. If YCANTH comes in contact with the eyes, flush eyes with water for at least 15 minutes and seek medical attention immediately.

5.2Local Skin Reactions YCANTH is a vesicant. Local skin reactions at the application site were observed in 97% of subjects treated with YCANTH during clinical trials. Local skin reactions included vesiculation, pruritus, pain, discoloration, and erythema [see Adverse Reactions (6.1) ] .

Avoid application near the eyes and mucosal tissues, and to adjacent healthy skin. If YCANTH contacts any unintended surface, including healthy skin, immediately remove by wiping with a cotton swab or gauze . Avoid other topical products (e.g. creams, lotions, or sunscreen) on treated areas until 24 hours after YCANTH treatment or until washing.

Application of other topical products could spread YCANTH and cause blistering or other adverse reactions to healthy skin. If severe blistering, severe pain or other severe adverse reactions occur, remove YCANTH prior to the recommended 24 hours after administration by washing with soap and water .

5.3Flammability YCANTH is a flammable liquid, even after drying. Avoid fire, flame or smoking near lesion(s) during treatment and after application until removed.

🤒 Adverse Reactions ~2 min read ▾

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.

6.1Clinical 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.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy 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.

8.2Lactation 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.

8.4Pediatric 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 .

8.5Geriatric Use Risk Summary YCANTH has not been studied in geriatric patients.

🤰 Pregnancy 127 words ▾

🧒 Pediatric Use 92 words ▾

🧓 Geriatric Use 13 words ▾

8.5Geriatric Use Risk Summary YCANTH has not been studied in geriatric patients.

🆘 Overdosage 55 words ▾

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.

🧬 Clinical Pharmacology 135 words ▾

12 CLINICAL PHARMACOLOGY

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

12.2Pharmacodynamics Cantharidin is a vesicant. The pharmacodynamics of cantharidin in the treatment of molluscum contagiosum are unknown.

12.3Pharmacokinetics Pharmacokinetics of cantharidin were assessed in 16 subjects aged 2 years and older with at least 21 molluscum contagiosum lesions at baseline. Subjects were administered a single, dermal application of cantharidin solution to each lesion. The average number of lesions treated for subjects in the exposure treatment group was 47.4 (median was 35.0).

Cantharidin was not detectable in 15 out of 16 subjects. Only one subject had a detectable cantharidin plasma level of 3.391 ng/mL at the 2-hour post-dose. Drug Interaction Studies No studies evaluating the drug interaction potential of cantharidin have been conducted.

🧬 Mechanism of Action 18 words ▾

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

📦 How Supplied / Storage and Handling 200 words ▾

16 HOW SUPPLIED/ STORAGE AND HANDLING

16.1How 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.

16.2Storage 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.

📦 Storage and Handling 29 words ▾

16.2Storage 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.

📋 Description 129 words ▾

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

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient and/or caregivers to read the FDA-approved patient labeling (Patient Information). Toxicities Associated with Inappropriate Administration Inform patients and/or caregivers that YCANTH can be fatal if ingested orally. Instruct patients and/or caregivers to avoid oral contact and to avoid touching lesions after YCANTH treatment.

If YCANTH is accidentally ingested, inform patients and/or caregivers to seek medical attention immediately. Advise patients and/or caregivers that severe eye injury can occur if YCANTH gets into the eyes. If YCANTH gets in the eyes, advise patients and/or caregivers to flush eyes with water for at least 15 minutes and seek medical attention immediately [see Warnings and Precautions (5.1) ] .

Local Skin Reactions Inform patients and/or caregivers that treatment with YCANTH can lead to local skin reactions [see Adverse Reactions (6.1) ] . Advise patients and/or caregivers not to use other topical products (e.g. creams, lotions, or sunscreen) until 24 hours after YCANTH treatment or until washing. Advise patients and/or caregivers to remove YCANTH with soap and water prior to 24 hours after treatment and contact the healthcare provider if severe blistering, severe pain or other severe adverse reactions occur [see Warnings and Precautions (5.2) ] .

Flammability Inform patients and/or caregivers that YCANTH is flammable, even after drying. Instruct patients and/or caregivers to avoid fire, flame, or smoking near the lesions treated with YCANTH until YCANTH is removed [see Warnings and Precautions (5.3) ] . Important Dosage and Administration Information Inform patients and/or caregivers to remove YCANTH with soap and water 24 hours after treatment.

Inform patients and/or caregivers that more than one YCANTH treatment may be necessary [see Dosage and Administration (2.2) ].

Glossary — plain-language definitions of medical terms used in this label:

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

Active ingredient: The part of a medicine that produces its intended effect on the body.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

coagulopathy: A problem with the blood's ability to clot properly, which can cause too much bleeding or unwanted clotting.

contact dermatitis: A skin rash caused by touching something that irritates the skin or triggers an allergy.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

dermatitis: Inflammation of the skin, causing redness, itching, and sometimes swelling or blisters.

discontinuation rate: The share of people in a study who stopped taking a treatment before the study was finished.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

edema: Swelling caused by extra fluid trapped in the body's tissues.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

Inactive ingredient: A component of a medicine, such as a filler, binder, or dye, that does not produce the intended effect.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

lactation: The making and release of milk from a mother's breasts after giving birth.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

perforation: A hole that forms all the way through the wall of the stomach or intestine.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

pruritus: Itching of the skin.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

topical: Applied onto the skin, eyes, or another body surface to work mainly where it is placed.

treatment-emergent: Describes a side effect that first appears, or gets worse, after a person starts taking a treatment.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

← 71347-0500-04 · The 71349-0999-01 · Verrica →

For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.

YCANTH Cantharidin 3.2 mg/.45mL Solution, 1 applicator

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