FDA.reportPublic FDA data

FUNGAL NAIL TREATMENT

Manufacturer
Jiangxi He-Oumei Health Industry Co., Ltd.
Effective date
2026-01-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:36:51

Label at a glance#

ProductFUNGAL NAIL TREATMENT
Active ingredientACETIC ACID
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Acetic Acid

OTC - PURPOSE SECTION

Treatment for toenail fungus

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of children section

INDICATIONS & USAGE SECTION

Treatment for toenail fungus

WARNINGS SECTION

keep out of children

DOSAGE & ADMINISTRATION SECTION

Apply to the affected area of the nail

INACTIVE INGREDIENT SECTION

Ethanol,Glycerol,Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87365-771-32FUNGAL NAIL TREATMENT1 in 1 APPLICATORCREAM11
87365-771-32FUNGAL NAIL TREATMENT5 in 1 BOXCREAM51

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87365-77187365-771-32

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
2-(ETHYLSULFONYL)ETHANOL95YYW1049KIACT
ACETIC ACIDQ40Q9N063PACTIB
WATER059QF0KO0RIACT

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
FUNGAL NAIL TREATMENTFUNGAL NAIL TREATMENTJiangxi He-Oumei Health Industry Co., Ltd.4922f627-167a-1783-e063-6394a90acd6f2026-01-24WarningsExact identifier
ndc (package): 87365-771-32
ndc (product): 87365-771
ndc11 (package): 87365077132
spl id: 4922f627-167b-1783-e063-6394a90acd6f
spl set id: 4922f627-167a-1783-e063-6394a90acd6f

Reported adverse events (FAERS/openFDA)#

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