FDA.reportPublic FDA data

Active ingredients

Manufacturer
Shenzhen Earth Surface Trading Co., Ltd.
Effective date
2026-05-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:57:50

Label at a glance#

ProductNail Repair Pen
Active ingredientUNDECYLENIC ACID
Label structure10 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

Undecylenic Acid 25%

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

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, Lonicera Japonica Flower Extract, Angelica Sinensis Root Extract, Glycerin, Allantoin, Garlic Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Aloe Barbadensis Leaf Extract

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0101

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85636-021-01Nail Repair Pen6 mL in 1 BOTTLELIQUID61

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85636-02185636-021-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALLANTOIN344S277G0ZIACT
ANGELICA ACUTILOBA ROOT3W51R3EK30IACT
WATER059QF0KO0RIACT
UNDECYLENIC ACIDK3D86KJ24NACTIB
TEA TREE OILVIF565UC2GIACT
ALOEV5VD430YW9IACT
GLYCERINPDC6A3C0OXIACT
GARLICV1V998DC17IACT
LONICERA JAPONICA FLOWER4465L2WS4YIACT

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
Nail Repair PenNAIL REPAIR PENShenzhen Earth Surface Trading Co., Ltd.520f6514-6660-d6a8-e063-6394a90adf822026-05-17WarningsExact identifier
ndc (package): 85636-021-01
ndc (product): 85636-021
ndc11 (package): 85636002101
spl id: 520f6c97-9697-e27a-e063-6394a90a51fc
spl set id: 520f6514-6660-d6a8-e063-6394a90adf82

Reported adverse events (FAERS/openFDA)#

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