85248-196

Manufacturer
Jiangxi Yudexi Pharmaceutical Co., LTD | Jiangxi Zhongletang Pharmaceuticals Co.,Ltd.
Effective date
2026-04-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:54:52

Label at a glance#

ProductYAMANGU FUNGAL NAIL REPAIR PEN
Active ingredientUNDECYLENIC ACID, TOLNAFTATE
Label structure13 sections

Dosage and administration

For athlete's foot and ringworm:use daily for 4 weeks. Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. 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. To ...

Storage and handling

Store at room temperature 15-30℃ (59-86℉)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Undecylenic acid 25% Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Use

INDICATIONS & USAGE SECTION

Treats most Athlete's Foot(Tinea Pedis) and Ringworm.
Relieves itching,scaling, cracking, burning, redness, soreness, and irritation and discomfort. Helps prevent most athlete's foot (dermatophytosis) with daily use.

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, there is no improvement within 4 weeks (for athlete's foot and ringworm).

Ask Doctor

OTC - ASK DOCTOR SECTION

irritation occurs, there is no improvement within 4 weeks (for athlete's foot and ringworm).

Keep Out Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION


For athlete's foot and ringworm:use daily for 4 weeks.
Clean the affected area and dry thoroughly.
Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor.
Supervise children in the use of this product.
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.
To prevent athlete's foot, apply once or twice daily (morning and/or night).
Apply to skin around the nail and cuticle.

Other information

STORAGE AND HANDLING SECTION

Store at room temperature 15-30℃ (59-86℉)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Tea tree oil,glycerin,polyethylene glycol.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

25 125 1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionPSN1
2691548tolnaftate 10 MG/ML / undecylenic acid 250 MG/ML Topical SolutionSCD1
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-136979843981699GTIN-13: 6979843981699
EAN-13: 6979843981699
GTIN storage (14 digits): 06979843981699
d10202b1124874f52b2b622846faeedd.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85248-196-01YAMANGU FUNGAL NAIL REPAIR PEN3 mL in 1 TUBELIQUID31
85248-196-01YAMANGU FUNGAL NAIL REPAIR PEN6 in 1 BOXLIQUID61

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85248-19685248-196-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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
YAMANGU FUNGAL NAIL REPAIR PENUNDECYLENIC ACID 25% TOLNAFTATE 1% FUNGAL NAIL REPAIR PENJiangxi Yudexi Pharmaceutical Co., LTD501cf54a-31da-6db2-e063-6394a90a65f82026-04-23WarningsExact identifier
ndc (package): 85248-196-01
ndc (product): 85248-196
ndc11 (package): 85248019601
spl id: 501cf54a-31db-6db2-e063-6394a90a65f8
spl set id: 501cf54a-31da-6db2-e063-6394a90a65f8

Reported adverse events (FAERS/openFDA)#

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