FDA.reportPublic FDA data

Nail Repair Pen

Manufacturer
Shenzhen Hengkaifeng Commerce and Trade Co., Ltd
Effective date
2024-03-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:09:36

Label at a glance#

ProductNail Repair Pen
Active ingredientTOLNAFTATE
Label structure11 sections

Indications and uses

Uses for relief and treatment of pain,soreness, and inflammation from nail fungus. Symptoms: ■ discolored nails ■ brittle nails ■ distorted nails

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate ≤1%

PURPOSE

OTC - PURPOSE SECTION

Anti-fungal

Uses

INDICATIONS & USAGE SECTION

Uses for relief and treatment of pain,soreness, and inflammation from nail fungus.
Symptoms: ■ discolored nails ■ brittle nails ■ distorted nails

Warnings

WARNINGS SECTION

For external use only, Some individuals may be sensitive to essential oils.
Begin with a small drop to determine if product causes any irritation. Discontinue use if any irritation occurs.
Stop use and consult a doctor if condition worsens, Not for use on children under the age of 2 without physician direction.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occur

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skik

When using this product

OTC - WHEN USING SECTION

Directions shake well before use.
Wash and thoroughly dry the affected area.
Apply 1-2 drops and gently rub into affected area three times per day.
Wash hands after applying

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallwed, get medical help or contact a Poison Control Center right away.

inactive ingredients

INACTIVE INGREDIENT SECTION

Water

Lonicerae Japonicae flos

Angelicae

Glycerin

Allantoin

Garlic Extract

Tea Tree Oil

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

shake well before use.Wash and thoroughly dry the affectedarea. Apply 1-2 drops and gently rubinto affected area three times per day.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
84117-001-012026-01-29C16284748780-149896155-a2fd-586f-e063-e6dba90add9012f6dbcc-1163-338c-e063-6394a90a66bc

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84117-001-01Nail Repair Pen5 g in 1 BOTTLELIQUID51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84117-001NAIL REPAIR PEN LIQUID [SHENZHEN HENGKAIFENG COMMERCE AND TRADE CO., LTD]11 package rows20240310_12f6dbcc-1163-338c-e063-6394a90a66bc.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84117-00184117-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
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
12f6dbcc-1164-338c-e063-6394a90a66bc12f6dbcc-1163-338c-e063-6394a90a66bc2024-03-05WarningsExact identifier
spl id: 12f6dbcc-1164-338c-e063-6394a90a66bc
spl set id: 12f6dbcc-1163-338c-e063-6394a90a66bc

Reported adverse events (FAERS/openFDA)#

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