Dr. Luke Fungal Nail Renewal

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 Fungal Nail Renewal
Active ingredientTOLNAFTATE
Label structure12 sections

Dosage and administration

Apply it in the day and night(twice a day). Before using it for the first time.soak the diseased nail withwarm water to soften it, use thenail file to polish the nail, make itthin visibly, and scrape off thedirt on the nail (be careful not tohurt the nail bed), then apply the liquid. After first use, every 2-3 daysuse the nail file to polish thesurface of the diseased nail andthen continue to use it. lf swallowed,...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Antifungal Disinfectant Treatment Solution

Use

INDICATIONS & USAGE SECTION

For all caused by nail fungus
nail discoloration
nail thickening
nail splitting
nail crumbling

Warnings

WARNINGS SECTION

For external use on nail
fungus(onychomycosis) only, pleasedon't use it on healthy nails
Don't use it on damaged skin,otherwise, your damaged skin maybe painful.
For people with severe skinulceration, please use it with caution.
Don't drink, avoid contact with your eye
Children use it under thesupervision of adults.
This product cannot replacemedicine.

Do not use

OTC - DO NOT USE SECTION

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

fungal infection itching

STOP USE section

OTC - STOP USE SECTION

You are allergic to vinegarsuch as itching, rash swelling of thelips, eyelids, and shortness ofbreath

ASK DOCTOR

OTC - ASK DOCTOR SECTION

You are allergic to vinegarsuch as itching, rash swelling of thelips, eyelids, and shortness ofbreath

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply it in the day and night(twice a day).
Before using it for the first time.soak the diseased nail withwarm water to soften it, use thenail file to polish the nail, make itthin visibly, and scrape off thedirt on the nail (be careful not tohurt the nail bed), then apply the liquid.
After first use, every 2-3 daysuse the nail file to polish thesurface of the diseased nail andthen continue to use it.
lf swallowed, get medical helpor contact a poison controlcenter right away.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Acetic Acid, SophoraFlavescens,StelleraChamaejasme Linn., ChineseGolden Larch Bark, FructusCnidii, Crocus Sativus L, Ethanol

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

83176-006-01

83176-006-0183176-006-01

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83176-00683176-006-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
276472ac-be62-d299-e063-6394a90a427ef8cc5335-fe24-7e63-e053-6294a90ad42a2024-11-20WarningsExact identifier
spl set id: f8cc5335-fe24-7e63-e053-6294a90ad42a

Reported adverse events (FAERS/openFDA)#

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