85248-165update

Manufacturer
Jiangxi Yudexi Pharmaceutical Co., LTD
Effective date
2026-07-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-07-28 05:10:13

Label at a glance#

ProductSERYNTH ANTIFUNGAL NAIL TREATMENT PEN
Active ingredientUNDECYLENIC ACID
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 pr...

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%

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 Oot 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

2525

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85248-16585248-165-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-03-18full-release2026-06-01 01:50:46

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
SERYNTH ANTIFUNGAL NAIL TREATMENT PENUNDECYLENIC ACID 25% ANTIFUNGAL NAIL TREATMENT PENJiangxi Yudexi Pharmaceutical Co., LTD4d59116a-bcd0-9ed4-e063-6394a90a6dbd2026-07-24WarningsExact identifier
ndc (package): 85248-165-01
ndc (product): 85248-165
ndc11 (package): 85248016501
spl id: 5767311b-d77d-a912-e063-6394a90afe09
spl set id: 4d59116a-bcd0-9ed4-e063-6394a90a6dbd

Reported adverse events (FAERS/openFDA)#

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