85248-218update

Manufacturer
Jiangxi Yudexi Pharmaceutical Co., LTD
Effective date
2026-07-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-07-22 05:10:10

Label at a glance#

ProductTrpWinner TOENAIL FUNGUS PEN
Active ingredientUNDECYLENIC ACID
Label structure13 sections

Dosage and administration

Clean the affected area and dry thoroughly. Apply a thin layer of the product over the affected area twice daily, morning and night, or as directed by a doctor. For athlete’s foot, pay special attention to spaces between the toes. Wear well‑fitting, ventilated shoes and change shoes and socks at least once daily. For athlete’s foot and ringworm, use daily for 4 weeks. If the condition persists longer, consult a do...

Storage and handling

Store at room temperature 15°C–30°C / 59°F–86°F. Keep tightly closed when not in use.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Undecylenic acid 25%

Purpose

OTC - PURPOSE SECTION

Antifungal

Use

INDICATIONS & USAGE SECTION

Treats most athlete's foot (tinea pedis) and ringworm (tinea corporis).
Relieves itching, scaling, cracking, burning, redness, soreness, irritation, and discomfort.

Warnings

WARNINGS SECTION

For external use only.

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

irritation occurs, or there is no improvement within 4 weeks.

Ask Doctor

OTC - ASK DOCTOR SECTION

irritation occurs, or there is no improvement within 4 weeks.

Keep Out Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Clean the affected area and dry thoroughly.
Apply a thin layer of the product over the affected area twice daily, morning and night, or as directed by a doctor.
For athlete’s foot, pay special attention to spaces between the toes. Wear well‑fitting, ventilated shoes and change shoes and socks at least once daily.
For athlete’s foot and ringworm, use daily for 4 weeks. If the condition persists longer, consult a doctor.

Other information

STORAGE AND HANDLING SECTION

Store at room temperature 15°C–30°C / 59°F–86°F.
Keep tightly closed when not in use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Isopropyl Alcohol, Alcohol Denat, Menthol, Glycerin, Borneol.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2525

Products#

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85248-21885248-218-01

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-05-20full-release2026-06-01 01:58:11

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
TrpWinner TOENAIL FUNGUS PENUNDECYLENIC ACID 25% TOENAIL FUNGUS PENJiangxi Yudexi Pharmaceutical Co., LTD523c2a9c-3b35-bf73-e063-6394a90ae17d2026-07-20WarningsExact identifier
ndc (package): 85248-218-01
ndc (product): 85248-218
ndc11 (package): 85248021801
spl id: 5708d86a-ec8b-ff0a-e063-6294a90a852d
spl set id: 523c2a9c-3b35-bf73-e063-6394a90ae17d

Reported adverse events (FAERS/openFDA)#

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