FDA.reportPublic FDA data

TOENAIL FUNGUS TREATMENT Liquid

Manufacturer
Guangzhou Ruijiu Electronic Technology Co., Ltd.
Effective date
2024-09-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:18:41

Label at a glance#

ProductTOENAIL FUNGUS TREATMENT Liquid
Active ingredientTOLNAFTATE, UNDECYLENIC ACID
Label structure13 sections

Storage and handling

heat above 40'C(104°) Store between 15° to 30 °C (59°to 86 ℉ )Avoid freezing and excessive

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

TOENAIL FUNGUS TREATMENT Liquid

OTC - ACTIVE INGREDIENT SECTION

TOLNAFTATE 1%
UNDECYLENIC ACID 25%

OTC - PURPOSE SECTION

Anti-fungal

INDICATIONS & USAGE SECTION

For the effective treatment of nail fungus, discoloration, thickeningsplitting,crumbling and brittleness.

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Children under 2 years of age.
pregnant or if there is any allergic reaction to this produce.

OTC - WHEN USING SECTION

When using this product Avoid contact with eyes

OTC - STOP USE SECTION

Stop use and ask a doctor if lrritation occurs or discomfort persists.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product gets into eyes,flush with water for 15 minutes.

If swallowed,get medical help or contact a Poison Control Centerright away.

DOSAGE & ADMINISTRATION SECTION

For initial use, soak the affected nail in warm water to soften it.Gently fle thenail to make it thinner and remove dirt, being cautiousnot to harm the nail bed.
Apply full layers of nail solution with brush onto affected areas onaround ,and under nails. A light tingle or burn is normal for the frst10 minutes until the product is absorbed into the skin.
Apply the product twice a day, in the morning and at night.
Visible results will be seen in as little as 6 weeks, continue regularusage to prevent fungus regrowth.

STORAGE AND HANDLING SECTION

heat above 40'C(104°)
Store between 15° to 30 °C (59°to 86 ℉ )Avoid freezing and excessive

INACTIVE INGREDIENT SECTION

ALCOHOL
DIMETHICONE
CETOSTEARYL ALCOHOL
TEA TREE OIL
PROPYLENE GLYCOL
TOCOPHEROL
SAFFLOWER OIL
WATER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionPSN1
2691548tolnaftate 10 MG/ML / undecylenic acid 250 MG/ML Topical SolutionSCD1
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83767-701-01TOENAIL FUNGUS TREATMENT Liquid30 mL in 1 BOTTLELIQUID301
83767-701-01TOENAIL FUNGUS TREATMENT Liquid1 in 1 PACKAGELIQUID11
83767-701-02TOENAIL FUNGUS TREATMENT Liquid30 mL in 1 BOTTLELIQUID301
83767-701-02TOENAIL FUNGUS TREATMENT Liquid2 in 1 PACKAGELIQUID21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83767-701TOENAIL FUNGUS TREATMENT LIQUID (TOLNAFTATE, UNDECYLENIC ACID) LIQUID [GUANGZHOU RUIJIU ELECTRONIC TECHNOLOGY CO., LTD.]14 package rows20240904_2134a379-6011-8b52-e063-6294a90a7c93.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83767-70183767-701-01, 83767-701-02

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
TEA TREE OILVIF565UC2GIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
TOCOPHEROLR0ZB2556P8IACT
TOLNAFTATE06KB629TKVACTIB
SAFFLOWER OIL65UEH262ISIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
DIMETHICONE92RU3N3Y1OIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
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
2134a379-6012-8b52-e063-6294a90a7c932134a379-6011-8b52-e063-6294a90a7c932024-09-03WarningsExact identifier
spl id: 2134a379-6012-8b52-e063-6294a90a7c93
spl set id: 2134a379-6011-8b52-e063-6294a90a7c93

Reported adverse events (FAERS/openFDA)#

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