ViLLsure Antifungal Pen

Manufacturer
Jiangxi Yudexi Pharmaceutical Co., LTD
Effective date
2026-03-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:48:48

Label at a glance#

ProductViLLsure Antifungal Pen
Active ingredientUNDECYLENIC ACID
Label structure13 sections

Dosage and administration

Prep: Wash the affected area with soap and water. Soak the nail to soften it.For toenail fungus:Gently file thickened areas of the nail every 2-3 days (avoid damaging nail bed). Apply a thin laver over the entire nail surface, under the nail edge, and around the cuticle. Use twice daily:morning and evening for at least 6 weeks. For best results,continue use for 3-6 months or as directed by a doctor.For athlete's f...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Undecylenic acid 25%

Purpose

OTC - PURPOSE SECTION

Antifungal

Use

INDICATIONS & USAGE SECTION

Helps prevent fungal infections, incuding tinea pedis (toenail onych omycosis). Relieves itching, burning, and cracking. Cures athlete's foot

Warnings

WARNINGS SECTION

For external use only. If pregnant or breastfeeding, consult a healthcare professional before use.

Do not use

OTC - DO NOT USE SECTION

on children under 2 years of age unless directed by a doctor.

When Using

OTC - WHEN USING SECTION

avoid contact with eyes.

Stop Use

OTC - STOP USE SECTION

there is no improvement within 4 weeks.iritation occurs.

Ask Doctor

OTC - ASK DOCTOR SECTION

there is no improvement within 4 weeks.iritation occurs.

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

lf accidental ingestion occurs, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Prep: Wash the affected area with soap and water. Soak the nail to soften it.For toenail fungus:Gently file thickened areas of the nail every 2-3 days (avoid damaging nail bed). Apply a thin laver over the entire nail surface, under the nail edge, and around the cuticle. Use twice daily:morning and evening for at least 6 weeks. For best results,continue use for 3-6 months or as directed by a doctor.For athlete's foot: Apply to affected areas and between toes. Allow product to dry fully before putting on socks or shoes.

Other information

OTC - STOP USE SECTION

Store at room temperature 15℃-30℃(59ºF-86ºF). Close cap tightly after each use.Keep away from direct sunlight and excessive moisture.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Almond Oil, Tea Tree Oil, Mineral Oil, Peppermint Oil, Tocopherol (Vitamin E).

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2525

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998329undecylenic acid 25 % Topical SolutionPSN1
998329undecylenic acid 250 MG/ML Topical SolutionSCD1
998329undecylenic acid 25 % Topical SolutionSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85248-151-01ViLLsure Antifungal Pen3 mL in 1 TUBELIQUID31
85248-151-01ViLLsure Antifungal Pen5 in 1 BOXLIQUID51

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85248-15185248-151-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ViLLsure Antifungal PenUNDECYLENIC ACID 25%ANTIFUNGAL PENJiangxi Yudexi Pharmaceutical Co., LTD4c28cf04-94ad-8db6-e063-6394a90a2eed2026-03-03WarningsExact identifier
ndc (package): 85248-151-01
ndc (product): 85248-151
ndc11 (package): 85248015101
spl id: 4c28cf04-94ae-8db6-e063-6394a90a2eed
spl set id: 4c28cf04-94ad-8db6-e063-6394a90a2eed

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.