FDA.reportPublic FDA data

85038-005 Fungal Nail Patches

Manufacturer
Lianjiang Shanlilai E-commerce Co., Ltd.
Effective date
2026-04-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:52:28

Label at a glance#

ProductFungal Nail Patches
Active ingredientUNDECYLENIC ACID, TOLNAFTATE
Label structure12 sections

Storage and handling

Store at room temperature and avoid excessive heat and direct sunlight.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Fungal Nail Patches

OTC - ACTIVE INGREDIENT SECTION

TOLNAFTATE 1%
UNDECYLENIC ACID 25%

OTC - PURPOSE SECTION

Anti-fungal

INDICATIONS & USAGE SECTION

Repairs fungal nail damage and improves nail appearance.

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on any skin with inflammation,infectlon, or redness.

Do not use if preqnant or if there is an allergic reaction to this product

Avoid contact with eyes.

OTC - STOP USE SECTION

Stop use and ask a doctor if lrritation occurs or discomfort persists

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

in case of accidental ingestion, seek medical advice immediatelyor contact a Poison Control Center right away

DOSAGE & ADMINISTRATION SECTION

Clean and prepare the affected nail.
Apply the fungal nail patch. Firmly secure the patch tothe sides of the toes or fingers, folding the remainingadhesive part to fully cover the toesffingertips.

Leave the patch on for 6 -8 hours. Use the patchesconsistently before bed for 3 -é months.

Maintain good foot hygiene.

STORAGE AND HANDLING SECTION

Store at room temperature and avoid excessive heat and direct sunlight.

INACTIVE INGREDIENT SECTION

Polyester Spandex
Acrylate Copolymer
Tackifying Resin
Glycerin
Water
Silicone Oil Paper

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label1label1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2700164tolnaftate 1 % / undecylenic acid 25 % Medicated PatchPSN2
2700164tolnaftate 0.01 MG/MG / undecylenic acid 0.25 MG/MG Medicated PatchSCD2
2700164tolnaftate 1 % / undecylenic acid 25 % Medicated PatchSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85038-005-01Fungal Nail Patches1 in 1 PATCHPATCH12
85038-005-01Fungal Nail Patches20 in 1 PACKAGEPATCH202

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
85038-00585038-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%)M4PPW69Y4HIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
UNDECYLENIC ACIDK3D86KJ24NACTIB
TOLNAFTATE06KB629TKVACTIB

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
Fungal Nail PatchesTOLNAFTATE, UNDECYLENIC ACIDLianjiang Shanlilai E-commerce Co., Ltd.299a63ad-f321-117c-e063-6394a90a3a222026-04-02WarningsExact identifier
ndc (package): 85038-005-01
ndc (product): 85038-005
ndc11 (package): 85038000501
spl id: 4e77eb19-8763-ad20-e063-6294a90acee1
spl set id: 299a63ad-f321-117c-e063-6394a90a3a22

Reported adverse events (FAERS/openFDA)#

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