Foot Cure Nail Repair Pen

Manufacturer
SANSAR, LLC
Effective date
2025-04-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:59:47

Label at a glance#

ProductFoot Cure Nail Repair Pen
Active ingredientUNDECYLENIC ACID
Label structure12 sections

Indications and uses

For the Effective treatment of nail fungus, discoloration, thickening, splitting, crumbling and britteleness 

Dosage and administration

1. Apply the product twice a day, in the morning and at night. 2. For initial use, soak the affected nail in warm water to soften it. Gently file the nail to make it thinner and remove dirt, being cautios not to harm the nail bed. For best results file nails every 2-3 days. 3. Use the Nail Repair pen brush to apply the solution on the affected areas. 4. Visible results will be seen in as little as 7 days, continue...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid 25%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses 

INDICATIONS & USAGE SECTION

For the Effective treatment of nail fungus, discoloration, thickening, splitting, crumbling and britteleness 

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 this product

OTC - WHEN USING SECTION

  • avoid contact with eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  •  irritation occurs or there is no improvement within 4 weeks.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

1. Apply the product twice a day, in the morning and at night.

2. For initial use, soak the affected nail in warm water to soften it. Gently file the nail to make it thinner and remove dirt, being cautios not to harm the nail bed. For best results file nails every 2-3 days.

3. Use the Nail Repair pen brush to apply the solution on the affected areas.

4. Visible results will be seen in as little as 7 days, continue regular usage to prevent fungus regrowth.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Vera Extract, Canola Oil, Clove bud oil, Lavender oil, Jojoba Oil, Manuka Oil, Oregano Oil, Peppermint Oil, Propolis Extract, Sweet Almond oil, Tea tree oil, Tocopheryl Acetate (Vitamin E)

NDC 83691-011-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4 Pen-jpg4 Pen-jpg

NDC 83691-011-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2 PEN2 PEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998329undecylenic acid 25 % Topical SolutionPSN1
998329undecylenic acid 250 MG/ML Topical SolutionSCD1
998329undecylenic acid 25 % Topical SolutionSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83691-011-01Foot Cure Nail Repair Pen4 in 1 CARTONSOLUTION41
83691-011-01Foot Cure Nail Repair Pen3 mL in 1 APPLICATORSOLUTION31
83691-011-02Foot Cure Nail Repair Pen2 in 1 CARTONSOLUTION21
83691-011-02Foot Cure Nail Repair Pen3 mL in 1 APPLICATORSOLUTION31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83691-011FOOT CURE NAIL REPAIR PEN (ANTIFUNGAL NAIL REPAIR PEN) SOLUTION [SANSAR, LLC]1Current NDC, 4 package rows20250427_9c823e27-8bb3-4ccd-bf7e-a99d45908e88.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83691-01183691-011-01, 83691-011-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
Foot Cure Nail Repair PenANTIFUNGAL NAIL REPAIR PENSANSAR, LLC9c823e27-8bb3-4ccd-bf7e-a99d45908e882025-04-25WarningsExact identifier
ndc (package): 83691-011-02
ndc (package): 83691-011-01
ndc (product): 83691-011
ndc11 (package): 83691001101
ndc11 (package): 83691001102
spl id: 533ce12a-7b84-4fd5-a296-a9b7e7ab4ad2
spl set id: 9c823e27-8bb3-4ccd-bf7e-a99d45908e88

Reported adverse events (FAERS/openFDA)#

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