FDA.reportPublic FDA data

SIDINOX TOENAIL FUNGUS TREATMENT Liquid

Manufacturer
Guangzhou Ruijiu Electronic Technology Co., Ltd.
Effective date
2024-09-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:19:00

Label at a glance#

ProductSIDINOX TOENAIL FUNGUS TREATMENT Liquid
Active ingredientUNDECYLENIC ACID, TOLNAFTATE
Label structure13 sections

Storage and handling

SHAKE WELL BEFORE USE. Store at 5'C to 30°0(41'F to 86°F) in a cool dry place. Keep tighosedand away from sunlight.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

SIDINOX TOENAIL FUNGUS TREATMENT Liquid

OTC - ACTIVE INGREDIENT SECTION

TOLNAFTATE 1%
UNDECYLENIC ACID 25%

OTC - PURPOSE SECTION

Anti-fungal

INDICATIONS & USAGE SECTION

Antifungal treatment for fingernails, toenails, and surrounding skin.Efective against fungal nails, athlete's fcot, tinea manuum,and ringworm caused by fungi.Addresses nail fungus, discoloralionthickening, splitling, and crumbling.

WARNINGS SECTION

Keep away from fire and flames.
Keep out of reach of children.
For external use on nails and the immediately adjacent skin only.

OTC - DO NOT USE SECTION

Do not use ifyou experience any signs of sensitivity or irritation

OTC - WHEN USING SECTION

While using this product:Not for use in the eyes, mouth, or vaginal area.

OTC - STOP USE SECTION

Stop use and consult a doctor if:
If the area of application shows increased irritation
If there is no improvement within 8 weeks.
If pregnant or breaslleeding.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children:
If accidental ingestion occurs, seek medical assistance or contact aPoison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Use once daily, preferably before bedtime.
Unscrew the bottle cap and use the brush to apply the medicine directlyto the nail.The medication will then penetrate deeply into the nail.
If the nail area is infected, spray the medication onto the affected area.

STORAGE AND HANDLING SECTION

SHAKE WELL BEFORE USE.
Store at 5'C to 30°0(41'F to 86°F) in a cool
dry place. Keep tighosedand away from sunlight.

INACTIVE INGREDIENT SECTION

ALCOHOL
DIMETHICONE
C12-15 ALKYL LACTATE
ETHYLHEXYLGLYCERIN
TOCOPHEROL
EDETATE DISODIUM
PHENOXYETHANOL
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
83767-801-01SIDINOX TOENAIL FUNGUS TREATMENT Liquid2 in 1 PACKAGELIQUID21
83767-801-01SIDINOX TOENAIL FUNGUS TREATMENT Liquid30 mL in 1 BOTTLELIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83767-801SIDINOX TOENAIL FUNGUS TREATMENT LIQUID (TOLNAFTATE, UNDECYLENIC ACID) LIQUID [GUANGZHOU RUIJIU ELECTRONIC TECHNOLOGY CO., LTD.]12 package rows20240907_216b23b8-265b-848d-e063-6294a90a28bb.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
83767-80183767-801-01

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
ALCOHOL3K9958V90MIACT
UNDECYLENIC ACIDK3D86KJ24NACTIB
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
TOLNAFTATE06KB629TKVACTIB
C12-15 ALKYL LACTATEGC844VRD7EIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
TOCOPHEROLR0ZB2556P8IACT
EDETATE DISODIUM7FLD91C86KIACT
PHENOXYETHANOLHIE492ZZ3TIACT

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
216b23b8-265c-848d-e063-6294a90a28bb216b23b8-265b-848d-e063-6294a90a28bb2024-09-05WarningsExact identifier
spl id: 216b23b8-265c-848d-e063-6294a90a28bb
spl set id: 216b23b8-265b-848d-e063-6294a90a28bb

Reported adverse events (FAERS/openFDA)#

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