FDA.reportPublic FDA data

FUNGAL NAIL REPAIR

Manufacturer
Shenzhen Furuizhilian keji Co., Ltd.
Effective date
2024-06-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:14:20

Label at a glance#

ProductFUNGAL NAIL REPAIR
Active ingredientACETIC ACID
Label structure9 sections

Storage and handling

Store at 59-86 °F(15-30°C)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACETIC ACID 17%

OTC - PURPOSE SECTION

Antifungal

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out ofreach ofchildren

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Flammable, keep away from fire and flames
For external use only

DOSAGE & ADMINISTRATION SECTION

Apply it in the day and night
Before using it for the first time, soak thediseased nail with warm water to soften it,use the nail file to polish the nail, make itthin visibly, and scrape off the dirt on thenail (be careful not to hurt the nail bed),then apply the liquid
After first use, every 2-3 days, use the nailfille to polish the surface of the diseasednail and then continue to use it

STORAGE AND HANDLING SECTION

Store at 59-86 °F(15-30°C)

INACTIVE INGREDIENT SECTION

Water, Alcohol, Phryma Leptostachya Extract,Salicylic Acid, Sophora Flavescens RootExtract, Garden Balsam (Impatiens Balsamina)Leaf Extract

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

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
84445-001-012025-07-29C16284748780-13b156c62-2edd-fb37-e063-e6dba90a4e07FUNGAL NAIL REPAIR
84445-001-022025-07-29C16284748780-13b156c62-2edd-fb37-e063-e6dba90a4e07FUNGAL NAIL REPAIR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84445-001-01FUNGAL NAIL REPAIR10 mL in 1 BOTTLELIQUID101
84445-001-02FUNGAL NAIL REPAIR35 mL in 1 BOTTLELIQUID351

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84445-001FUNGAL NAIL REPAIR (ACETIC ACID) LIQUID [SHENZHEN FURUIZHILIAN KEJI CO., LTD.]12 package rows20240628_1bc61670-59ca-c486-e063-6394a90abcbe.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84445-00184445-001-01, 84445-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
ACETIC ACIDQ40Q9N063PACTIB
WATER059QF0KO0RIACT
SALICYLIC ACIDO414PZ4LPZIACT
SOPHORA FLAVESCENS ROOTIYR6K8KQ5KIACT
PHRYMA LEPTOSTACHYA WHOLE6G287VJM69IACT
IMPATIENS BALSAMINA LEAFLH9E1X602VIACT

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
1bc61670-59cb-c486-e063-6394a90abcbe1bc61670-59ca-c486-e063-6394a90abcbe2024-06-26WarningsExact identifier
spl id: 1bc61670-59cb-c486-e063-6394a90abcbe
spl set id: 1bc61670-59ca-c486-e063-6394a90abcbe

Reported adverse events (FAERS/openFDA)#

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