85248-200 update

Manufacturer
Jiangxi Yudexi Pharmaceutical Co., LTD | Jiangxi Zhongletang Pharmaceuticals Co.,Ltd.
Effective date
2026-05-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:57:48

Label at a glance#

ProductBeukow 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 layer 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 athlet...

Storage and handling

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

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, including tinea pedis (toenail onychomycosis). Relieves itching, burning, and cracking. Cures athlete’s foot.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

If pregnant or breastfeeding, consult a healthcare professional before use.
Do not use on children under 2 years of age unless directed by a doctor.

When Using

OTC - WHEN USING SECTION

avoid contact with eyes.
Use only as directed by a doctor on persons with highly sensitive skin.

Stop Use

OTC - STOP USE SECTION

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

Ask Doctor

OTC - ASK DOCTOR SECTION

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

Keep Out Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If 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 layer 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

STORAGE AND HANDLING SECTION

Store at room temperature 15°C-30°C (59°F-86°F).
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 SolutionPSN2
998329undecylenic acid 250 MG/ML Topical SolutionSCD2
998329undecylenic acid 25 % Topical SolutionSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-136979843981804GTIN-13: 6979843981804
EAN-13: 6979843981804
GTIN storage (14 digits): 06979843981804
377782fd53cb8142bc1d71420d75ed26.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85248-200-01Beukow Antifungal Pen4 in 1 BOXLIQUID42
85248-200-01Beukow Antifungal Pen3 mL in 1 TUBELIQUID32

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
85248-20085248-200-01

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
12026-05-05weekly-update2026-06-03 18:02:32

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
Beukow Antifungal PenUNDECYLENIC ACID 25% ANTIFUNGAL PENJiangxi Yudexi Pharmaceutical Co., LTD511d1edf-dfda-477c-e063-6294a90aa4232026-05-17WarningsExact identifier
ndc (package): 85248-200-01
ndc (product): 85248-200
ndc11 (package): 85248020001
spl id: 520d9323-4bd5-5b79-e063-6294a90a49ce
spl set id: 511d1edf-dfda-477c-e063-6294a90aa423

Reported adverse events (FAERS/openFDA)#

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