FDA.reportPublic FDA data

SootheSense Toenail Fungus Treatment

Manufacturer
Guangdong Quadrant Ecological Technology Co., Ltd.
Effective date
2026-03-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:49:23

Label at a glance#

ProductSootheSense Toenail Fungus Treatment
Active ingredientUNDECYLENIC ACID
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

UNDECYLENIC ACID 25%

OTC - PURPOSE SECTION

Antifungal

INDICATIONS & USAGE SECTION


For the relief of itching, burningand irritation associated with these conditions
Helps in the treatment of antifungal infections on skin around nails

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on children under 2 years of age unless directed by a doctor.

OTC - WHEN USING SECTION

When using this product, avoid contact with eyes. lf contact occurs rinse thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor ifirritation occurs or there is no improvement within 4 weeks

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION


Clean and dry affected area
Apply a thin layer twice daily (morning and night).
Continue treatment for at least 4 weeks. For nail fungus, treatment may be required for 8-12 weeks

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

label1label1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1362039undecylenic acid 25 % Topical GelPSN1
1362039undecylenic acid 0.25 MG/MG Topical GelSCD1
1362039undecylenic acid 25 % Topical GelSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-136977863764834GTIN-13: 6977863764834
EAN-13: 6977863764834
GTIN storage (14 digits): 06977863764834		label1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76986-027-01SootheSense Toenail Fungus 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
76986-02776986-027-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
UREA8W8T17847WIACT
GLYCOLIC ACID0WT12SX38SIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
MENTHOLL7T10EIP3AIACT
HYDROXYPROPYLCELLULOSE9XZ8H6N6OHIACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILVIF565UC2GIACT
WATER059QF0KO0RIACT
EDETATE DISODIUM7FLD91C86KIACT
UNDECYLENIC ACIDK3D86KJ24NACTIB
ZANTHOXYLUM BUNGEANUM FRUIT3CIP16A418IACT
SALICYLIC ACIDO414PZ4LPZIACT

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
SootheSense Toenail Fungus TreatmentUNDECYLENIC ACIDGuangdong Quadrant Ecological Technology Co., Ltd.4ca2bbeb-3b8a-9482-e063-6294a90a57892026-03-09WarningsExact identifier
ndc (package): 76986-027-01
ndc (product): 76986-027
ndc11 (package): 76986002701
spl id: 4ca2bbeb-3b8b-9482-e063-6294a90a5789
spl set id: 4ca2bbeb-3b8a-9482-e063-6294a90a5789

Reported adverse events (FAERS/openFDA)#

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