Dr. Luke FUNGAL NAIL RENEWAL

Manufacturer
DANOUS LAND FLOOW LLC
Effective date
2025-11-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:43:07

Label at a glance#

ProductDr. Luke FUNGAL NAIL RENEWAL
Active ingredientTOLNAFTATE
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

OTC - PURPOSE SECTION

Antifungal Disinfectant Treatment Solution

INDICATIONS & USAGE SECTION

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

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.

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.

OTC - WHEN USING SECTION

fungal infection itching

OTC - STOP USE SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

INSTRUCTIONS FOR USE 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 INGREDIENT SECTION

Water, Acetic Acid, SophoraFlavescens,Stellera Chamaejasme whole, ChineseGolden Larch Bark, FructusCnidii, Crocus Sativus Whole, Ethanol,Cnidium Seed, Alcohol

OTHER SAFETY INFORMATION

  • Do not use if glued carton end flaps are open or if the tube seal is broken.
  • Store at 68°-77°F (20°-25C).
  • Keep container tightly closed

DOSAGE & ADMINISTRATION SECTION

Apply it in the day and night (twice a day)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313423tolnaftate 1 % Topical SolutionPSN1
313423tolnaftate 10 MG/ML Topical SolutionSCD1
313423tolnaftate 1 % Topical SolutionSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 128X003PPAZFX20251110-103914.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87147-005-01Dr. Luke FUNGAL NAIL RENEWAL30 mL in 1 BOTTLELIQUID301

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87147-00587147-005-01

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
43427b44-bdaa-bc1a-e063-6294a90aaed643427f16-59be-c0ee-e063-6294a90aee632025-11-10WarningsExact identifier
spl id: 43427b44-bdaa-bc1a-e063-6294a90aaed6
spl set id: 43427f16-59be-c0ee-e063-6294a90aee63

Reported adverse events (FAERS/openFDA)#

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