Pureskin FUNGAL NAIL RENEWAL PATCHES

Manufacturer
Stellans Inc.
Effective date
2024-07-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:58:40

Label at a glance#

ProductPureskin FUNGAL NAIL RENEWAL PATCHES
Active ingredientUNDECYLENIC ACID
Label structure10 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.

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Oot Of Reach Of Children

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

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83565-01183565-011-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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
21acf7d9-7963-5931-e063-6294a90a16571d46728f-baa2-2663-e063-6294a90af9de2024-09-09WarningsExact identifier
spl set id: 1d46728f-baa2-2663-e063-6294a90af9de

Reported adverse events (FAERS/openFDA)#

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