Pureskin FUNGAL NAIL RENEWAL PATCHES

Manufacturer
Xiamen Beishan Ecommerce Co.,LTD
Effective date
2024-10-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:24:00

Label at a glance#

ProductPureskin FUNGAL NAIL RENEWAL PATCHES
Active ingredientUNDECYLENIC ACID
Label structure9 sections

Dosage and administration

Begin by removing any nail polish. Cleanse nails and surrounding skin, ensuring thorough drying to enhance adhesion. a. Peel off protective films and sequentially. b. Apply the patch to the affected nail area, removing release paper. c. Firmly cover the sides of the toe or finger. d. Fold the remaining adhesive to envelop the toe/fingertip. e. Maintain the patch for 6-8 hours (overnight use recommended for 3-6 mon...

Storage and handling

Store at room temperature. Keep away from moisture and sunlight. Do not use if seal is broken or missing.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid 8%

Purpose

OTC - PURPOSE SECTION

Antifungal

Use

INDICATIONS & USAGE SECTION

For repairing nails affected by fungal infections

Warnings

WARNINGS SECTION

1. Keep out of children's reach. Avoid contact with eyes, mouth, mucous membranes, wounds, or inflamed skin.
2. External use only.
3. Do not use if allergic to any ingredient.
4. Do not use in children.
5. Do not use if pouch is torn or broken.
6. Discontinue use if skin becomes red, swollen, or itchy, and consult a healthcare professional.

Directions

DOSAGE & ADMINISTRATION SECTION

Begin by removing any nail polish. Cleanse nails and surrounding skin, ensuring thorough drying to enhance adhesion.
a. Peel off protective films and sequentially.
b. Apply the patch to the affected nail area, removing release paper.
c. Firmly cover the sides of the toe or finger.
d. Fold the remaining adhesive to envelop the toe/fingertip.
e. Maintain the patch for 6-8 hours (overnight use recommended for 3-6 months).
Use daily for optimal results. It is recommended to roughen the nail surface before application for better adhesion.

Other information

STORAGE AND HANDLING SECTION

Store at room temperature. Keep away from moisture and sunlight.
Do not use if seal is broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Polyester, Spandex, Acrylate Copolymer, Tackifying Resin, Glycerin, Water, Acrylic Copolymer, Silicone Oil, Paper

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2694118undecylenic acid 8 % Medicated PatchPSN1
2694118undecylenic acid 0.08 MG/MG Medicated PatchSCD1
2694118undecylenic acid 8 % Medicated PatchSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7fd951fe-040a-0b64-2bea-eefc6aa4fc54Product name220250515
5b0ed980-56ce-7dd0-fb86-ff54be67c2e6Product name220200925
eed31638-1288-4eb6-a55c-5fc014dca98dProduct name320200728

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83910-004-012025-07-29C16284748780-13b156c62-2bcc-fb37-e063-e6dba90a4e0783910-004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83910-004-01Pureskin FUNGAL NAIL RENEWAL PATCHES21 in 1 BOXPATCH211

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83910-004PURESKIN FUNGAL NAIL RENEWAL PATCHES PATCH [XIAMEN BEISHAN ECOMMERCE CO.,LTD]11 package rows20241011_24177cff-b723-fe86-e063-6394a90a2f54.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83910-00483910-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
2417780b-e50f-fa97-e063-6394a90af0d424177cff-b723-fe86-e063-6394a90a2f542024-10-09WarningsExact identifier
spl id: 2417780b-e50f-fa97-e063-6394a90af0d4
spl set id: 24177cff-b723-fe86-e063-6394a90a2f54

Reported adverse events (FAERS/openFDA)#

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