FUNGAL NAIL TREATMENT

Manufacturer
Guangdong Quadrant Ecological Technology Co., Ltd.
Effective date
2026-03-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:50:06

Label at a glance#

ProductFUNGAL NAIL TREATMENT
Active ingredientUNDECYLENIC ACID
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

UNDECYLENIC ACID 25%

OTC - PURPOSE SECTION

Renew Nails

INDICATIONS & USAGE SECTION

For the treatment of fungal infections of the nails Helps relieve itching, scaling, and discomfort associated with fungal infections

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

If you expenence any signs of sensitivity or imitation,discontinue use and consult a doctor

OTC - WHEN USING SECTION

When using this product Avoid contact with eyes

OTC - STOP USE SECTION

Stop use and ask a doctor iflf discomfort persists

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


if the product gets into your eyes, flush with water for 15 minutes.
if swallowed, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION SECTION


Use daily for at least 4 weeks or as directed by a doctor
Before use, clean the affected nail(s) and dry thoroughly.
Apply a thin layer of the product directly onto the affected nail, including the nail surface, edges, and cuticle area
Use twice daily (moming and evening)
Allow the solution to fully dry before covering the nail or wearing shoes/socks
For best results, continue use as directed
Supervise children in the use of this product.
This product is not intended for use on the scalpor skin other than around the nail

INACTIVE INGREDIENT SECTION

ALCOHOL
WATER
UREA
PROPYLENE GLYCOL
SALICYLIC ACID
MENTHOL
HYDROXYPROPYLCELLULOSE
ZANTHOXYLUM BUNGEANUM FRUIT EXTRACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL
DISODIUM EDTA
GLYCOLIC ACID

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998329undecylenic acid 25 % Topical SolutionPSN1
998329undecylenic acid 250 MG/ML Topical SolutionSCD1
998329undecylenic acid 25 % Topical SolutionSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76986-031-01FUNGAL NAIL TREATMENT30 mL in 1 BOTTLELIQUID301

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76986-03176986-031-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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 TREATMENTUNDECYLENIC ACIDGuangdong Quadrant Ecological Technology Co., Ltd.4ce3f0e2-b532-b89f-e063-6294a90a7e252026-03-13WarningsExact identifier
ndc (package): 76986-031-01
ndc (product): 76986-031
ndc11 (package): 76986003101
spl id: 4ce3f0e2-b533-b89f-e063-6294a90a7e25
spl set id: 4ce3f0e2-b532-b89f-e063-6294a90a7e25

Reported adverse events (FAERS/openFDA)#

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