FDA.reportPublic FDA data

FUNGAL NAIL TREATMENT MAXIMUM STRENGTH Liquid

Manufacturer
Guangzhou Ruijiu Electronic Technology Co., Ltd.
Effective date
2024-12-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:47:00

Label at a glance#

ProductFUNGAL NAIL TREATMENT MAXIMUM STRENGTH Liquid
Active ingredientTOLNAFTATE, UNDECYLENIC ACID
Label structure13 sections

Storage and handling

Store at room temperature 15--30°C(59°-86°F) Protect from freezing; if freezingoccurs, wamm to room temperature Keep tightly closed when not in use

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

FUNGAL NAIL TREATMENT MAXIMUM STRENGTH Liquid

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%
Undecylenic Acid 25%

OTC - PURPOSE SECTION

Anti-fungal and Nail Renewal

INDICATIONS & USAGE SECTION

Antifungal use on fingemails, toenails, and the immediately adjacent skin.
Prevents the recurence of most athlete's foot with daily use
For all caused by nail fungus, nail discoloration, nail thickening,nailsplitting, nail crumbling.

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

on children under 2 years of age unless directed by a doctor

OTC - WHEN USING SECTION

avoid contact with the eyes.

OTC - STOP USE SECTION

Imitation occurs
There is no improvement within 4 weeks

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If accidental ingestion occurs, get medical help or contact a PoisonControl Center right away.

DOSAGE & ADMINISTRATION SECTION

Apply once daily, preferably at bedtime or at least eight hours beforewashing. Clean and thoroughly dry the affected area, then use theapplicator brush provided to cover all affected nails. Ensure that theapplication is evenly distrnbuted across the entire nail plate

STORAGE AND HANDLING SECTION

Store at room temperature 15--30°C(59°-86°F)
Protect from freezing; if freezingoccurs, wamm to room temperature
Keep tightly closed when not in use

INACTIVE INGREDIENT SECTION

ALCOHOL
DIMETHICONE
C12-15 ALKYL LACTATE
ETHYLHEXYLGLYCERIN
SOPHORA FLAVESCENS ROOT
TOCOPHEROL
PHENOXYETHANOL
WATER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

label2label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionPSN2
2691548tolnaftate 10 MG/ML / undecylenic acid 250 MG/ML Topical SolutionSCD2
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83767-501-01FUNGAL NAIL TREATMENT MAXIMUM STRENGTH Liquid30 mL in 1 BOTTLELIQUID302
83767-501-01FUNGAL NAIL TREATMENT MAXIMUM STRENGTH Liquid2 in 1 PACKAGELIQUID22
83767-501-02FUNGAL NAIL TREATMENT MAXIMUM STRENGTH Liquid4 in 1 PACKAGELIQUID42
83767-501-02FUNGAL NAIL TREATMENT MAXIMUM STRENGTH Liquid30 mL in 1 BOTTLELIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83767-501FUNGAL NAIL TREATMENT MAXIMUM STRENGTH LIQUID (TOLNAFTATE) LIQUID [GUANGZHOU RUIJIU ELECTRONIC TECHNOLOGY CO., LTD.]24 package rows20241222_20b8ebbf-7ab8-c3e1-e063-6394a90a4037.zip

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
83767-50183767-501-01, 83767-501-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
C12-15 ALKYL LACTATEGC844VRD7EIACT
SOPHORA FLAVESCENS ROOTIYR6K8KQ5KIACT
DIMETHICONE92RU3N3Y1OIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
TOCOPHEROLR0ZB2556P8IACT
TOLNAFTATE06KB629TKVACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
UNDECYLENIC ACIDK3D86KJ24NACTIB

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
299b2aa3-b092-e5bb-e063-6394a90aa8a720b8ebbf-7ab8-c3e1-e063-6394a90a40372024-12-19WarningsExact identifier
spl id: 299b2aa3-b092-e5bb-e063-6394a90aa8a7
spl set id: 20b8ebbf-7ab8-c3e1-e063-6394a90a4037

Reported adverse events (FAERS/openFDA)#

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