85248-174update

Manufacturer
Jiangxi Yudexi Pharmaceutical Co., LTD
Effective date
2026-07-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-07-23 05:10:05

Label at a glance#

ProductLYSSERA Fungal Nail Renewal
Active ingredientUNDECYLENIC ACID
Label structure13 sections

Dosage and administration

1.Prep: Wash the affected area with soap and water. Soak the nail to soften it. 2.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. 3.For ...

Storage and handling

Store at room temperature 15-30°C (59-86°F). Keep away from direct sunlight and 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

1.For external use only.
2.Avoid contact with eyes
3.Stop use and consult a doctor if irritation occurs or condition worsens
4.Keep out of reach of children
5.If swallowed, get medical help or contact a Poison Control Center immediately

Do not use

OTC - DO NOT USE SECTION

on irritated, inflamed, or broken skin
if you are allergic to any of the ingredients in this product
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

Stop use and consult a doctor if irritation occurs or condition worsens

Ask Doctor

OTC - ASK DOCTOR SECTION

If swallowed, get medical help or contact a Poison Control Center immediately

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

1.Prep: Wash the affected area with soap and water. Soak the nail to soften it.
2.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.
3.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 15-30°C (59-86°F).
Keep away from direct sunlight and moisture.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Mineral Oil, Apricot Kernel Oil, Tea Tree Oil, Tocopherol (Vitamin E), Peppermint Oil, Camphor

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2525

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85248-17485248-174-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-03-26full-release2026-06-01 01:51:43

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
LYSSERA Fungal Nail RenewalUNDECYLENIC ACID 25% ANTIFUNGAJiangxi Yudexi Pharmaceutical Co., LTD4dea6df4-e66b-c24a-e063-6294a90afca72026-07-20WarningsExact identifier
ndc (package): 85248-174-01
ndc (product): 85248-174
ndc11 (package): 85248017401
spl id: 571699c5-113b-6a9d-e063-6294a90a445e
spl set id: 4dea6df4-e66b-c24a-e063-6294a90afca7

Reported adverse events (FAERS/openFDA)#

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