FDA.reportPublic FDA data

Foot Cure Nail Repair Pen

Manufacturer
Sansar LLC | 093638579
Effective date
2024-07-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:16:00

Label at a glance#

ProductFoot Cure Nail Repair Pen
Active ingredientUNDECYLENIC ACID
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid 25%...........................Antifungal

INTENDED USE OF THE DEVICE

For the effective treatment of nail fungus, discolartion, thickening, splitting, crumbling and brittleness.

WARNINGS SECTION

For external use only.

WARNINGS AND PRECAUTIONS SECTION

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

INACTIVE INGREDIENT SECTION

Alo 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)

DOSAGE & ADMINISTRATION SECTION

3ml X 4 Pen

INDICATIONS & USAGE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - PURPOSE SECTION

For the effective treatment of nail fungus, discolartion, thickening, splitting, crumbling and brittleness.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nail Repair PenNail Repair Pen

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83691-002FOOT CURE NAIL REPAIR PEN SOLUTION [SANSAR LLC]1Unmatched20240726_1e15de65-83b3-0899-e063-6394a90a64c7.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83691-00283691-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPOLIS WAX6Y8XYV2NOFIACT
UNDECYLENIC ACIDK3D86KJ24NACTIB
OREGANO LEAF OIL7D0CGR40U1IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
LAVENDER OILZBP1YXW0H8IACT
ALMOND OIL66YXD4DKO9IACT
CLOVE OIL578389D6D0IACT
PEPPERMINT OILAV092KU4JHIACT
JOJOBA OIL724GKU717MIACT
MANUKA OILM6QU9ZUH2XIACT
CANOLA OIL331KBJ17RKIACT
TEA TREE OILVIF565UC2GIACT
ALOE VERA WHOLEKIZ4X2EHYXIACT

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
3c9a7a34-ad06-405e-af13-21c60d1685811e15de65-83b3-0899-e063-6394a90a64c72026-01-09WarningsExact identifier
spl set id: 1e15de65-83b3-0899-e063-6394a90a64c7

Reported adverse events (FAERS/openFDA)#

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