Dr. Luke Nail Repair Pen

Manufacturer
Dr.luke Healthcare LLC
Effective date
2023-04-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:33:18

Label at a glance#

ProductDr. Luke Nail Repair Pen
Active ingredientUNDECYLENIC ACID
Label structure13 sections

Dosage and administration

1.Wash and dry nails before application. Remove the cap covering thebrush on the pen. 2.Twist the end of the pen clockwise to dispense liquid onto the brush. 3.Using the brush, apply a thin layer of liquid onto the affected area. 4.Let the area dry, then reapply another thin layer. Do this two more times. 5.Repeat this process 3 times daily for 6-8 weeks(or) until the infection is gone.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid 10%

Purpose

OTC - PURPOSE SECTION

Antifungal

Use

INDICATIONS & USAGE SECTION

Improving nail appearance
Antifungal of Candida albicans or other fungi
According to proven tests, the disinfecting time of the product on Candidaalbicans is 2 minutes and the average antibacterial rate is 100%

Warnings

WARNINGS SECTION

For external use on nailfungus(onychomycosis) only, pleasedon't use it on healthy nails
Don't use it on damaged skin,otherwise, your damaged skin maybe painful.
Avoid contact with your eye. This product cannot replace medicine.

Do not use

OTC - DO NOT USE SECTION

On damaged skin(cuts, abrasions, eczema, sunburn).
If you are allergic to any of the ingredients in this product.
If you are pregnant or breastfeeding.

WHEN USING SECTION

OTC - WHEN USING SECTION

Improving nail appearance
Antifungal of Candida albicans or other fungi
According to proven tests, the disinfecting time of the product on Candidaalbicans is 2 minutes and the average antibacterial rate is 100%

STOP USE section

OTC - STOP USE SECTION

You are allergic to this product (such as itching, rash swelling of the lips.evelids, and shortness of breath)

ASK DOCTOR

OTC - ASK DOCTOR SECTION

You are allergic to this product (such as itching, rash swelling of the lips.evelids, and shortness of breath)

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

1.Wash and dry nails before application. Remove the cap covering thebrush on the pen.
2.Twist the end of the pen clockwise to dispense liquid onto the brush.
3.Using the brush, apply a thin layer of liquid onto the affected area.
4.Let the area dry, then reapply another thin layer. Do this two more times.
5.Repeat this process 3 times daily for 6-8 weeks(or) until the infection is gone.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Deacetylation Chitin, Salicylic Acid, And Angelica Dahurica

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

83176-007-01

83176-007-0183176-007-01

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83176-00783176-007-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 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
27648245-e5d3-b1a0-e063-6294a90a4962f8cd4373-2203-5773-e053-6294a90ae3692024-11-20WarningsExact identifier
spl set id: f8cd4373-2203-5773-e053-6294a90ae369

Reported adverse events (FAERS/openFDA)#

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