FDA.reportPublic FDA data

Nail Fungus Treatment

Manufacturer
Guangzhou Maitelin Information Technology Co., Ltd.
Effective date
2024-04-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:10:57

Label at a glance#

ProductNail Fungus Treatment
Active ingredientSALICYLIC ACID
Label structure13 sections

Storage and handling

Store at room temperature 15°-30°C(59°-86°F) away from direct sunlight.Prevent freezing.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Nail Fungus Treatment

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 6.6%

OTC - PURPOSE SECTION

Anti-fungal

INDICATIONS & USAGE SECTION

Effective for fighting against fungalcausingbacteria of fingernails or toenails: thick orridged, discolored, gel manicure/pedicuredamage, aging & brittle.

WARNINGS SECTION

FOR EXTERNAL USE ONLY.

OTC - DO NOT USE SECTION

Don't use on children under 2 years ofage unless directed by a doctor.
Don't use it on damaged skin; otherwise, your damaged skin may be painful.
Don't use this product, if you are pregnantor nursing.

OTC - WHEN USING SECTION

Avoid eye contact, if contact occurs, rinsethoroughly with water.

OTC - STOP USE SECTION

Stop use and consult a doctor/healthcareprofessional if irritation or symptom-sworsen.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swal-lowed, get medical help or contact a poisoncontrol center right away.

DOSAGE & ADMINISTRATION SECTION

Read all package directions and warningsbefore use.
Before the first use, soak the diseasednail in warm water to soften it. Wash anddry thoroughly, gently polish the diseasednail with a nail file to make it thinner andremove dirt, taking care not to hurt the nailbed. Then apply the liquid.
Do not scrub within 1 hour after use.
Apply the product twice a day. (In themorning and night)
After the first application, every 2-3 daysfile the surface of the diseased nail andcontinue regular usage.

STORAGE AND HANDLING SECTION

Store at room temperature 15°-30°C(59°-86°F) away from direct sunlight.Prevent freezing.

INACTIVE INGREDIENT SECTION

AQUA
GARDEN BALSAM FLOWER
PHRYMA LEPTOSTACHYA WHOLE
STEMONAE RADIX
ANGELICA DAHURICA ROOT
PSEUDOLARIXAMABILIS BARK
ARTEMISIA ARGYI LEAF
ACETIC ACID
POLYOXYL 35 CASTOR OIL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabellabel2label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2679295salicylic acid 6.6 % Topical SolutionPSN1
2679295salicylic acid 66 MG/ML Topical SolutionSCD1
2679295salicylic acid 6.6 % Topical SolutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
84257-101-012025-07-29C16284748780-13b156c62-2d1d-fb37-e063-e6dba90a4e07Nail Fungus Treatment
84257-101-022025-07-29C16284748780-13b156c62-2d1d-fb37-e063-e6dba90a4e07Nail Fungus Treatment
84257-101-032025-07-29C16284748780-13b156c62-2d1d-fb37-e063-e6dba90a4e07Nail Fungus Treatment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84257-101-01Nail Fungus Treatment20 mL in 1 BOTTLELIQUID201
84257-101-02Nail Fungus Treatment25 mL in 1 BOTTLELIQUID251
84257-101-03Nail Fungus Treatment30 mL in 1 BOTTLELIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84257-101NAIL FUNGUS TREATMENT (SALICYLIC ACID) LIQUID [GUANGZHOU MAITELIN INFORMATION TECHNOLOGY CO., LTD.]13 package rows20240412_15c9eecf-1c3d-14ea-e063-6394a90a096f.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
84257-10184257-101-01, 84257-101-02, 84257-101-03

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
PHRYMA LEPTOSTACHYA WHOLE6G287VJM69IACT
ANGELICA DAHURICA ROOT1V63N2S972IACT
PSEUDOLARIX AMABILIS BARK49G13A93VEIACT
SALICYLIC ACIDO414PZ4LPZACTIB
WATER059QF0KO0RIACT
STEMONA SESSILIFOLIA ROOTEKG8030U4NIACT
IMPATIENS BALSAMINA FLOWER3169PS5TJHIACT
ARTEMISIA ARGYI LEAF2JYC99Q0WZIACT
ACETIC ACIDQ40Q9N063PIACT
POLYOXYL 35 CASTOR OIL6D4M1DAL6OIACT

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
15c9eecf-1c3e-14ea-e063-6394a90a096f15c9eecf-1c3d-14ea-e063-6394a90a096f2024-04-10WarningsExact identifier
spl id: 15c9eecf-1c3e-14ea-e063-6394a90a096f
spl set id: 15c9eecf-1c3d-14ea-e063-6394a90a096f

Reported adverse events (FAERS/openFDA)#

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