FDA.reportPublic FDA data

TEGASOLVE TOENAIL FUNGUS TREATMENT

Manufacturer
Zhengzhou Hangrui Network Technology Co., Ltd.
Effective date
2025-06-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:02:54

Label at a glance#

ProductTEGASOLVE 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 effective treatment of most nail fungus, athlete's foot, ringworm, andother skin fungus infections
Helps relieve symptoms such as discoloration, brittleness, thickened orcrumbling nails

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

On children under 2 years of age unless directed by a doctor

OTC - WHEN USING SECTION


Avoid contact with eyes
If contact occurs, rinse thoroughly with water

OTC - STOP USE SECTION


Irritation occurs
Condition does not improve within 4 weeks

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION


1, Clean and dry the affected area thoroughly before application
2, Apply a thin layer of the solution to the affected area twice daily(morningand night)
3, For best results, file affected nails every 2-3 days after soaking in warmwater
4, Continue use for at least 4 weeks, or as directed by a doctor

INACTIVE INGREDIENT SECTION

Aloe Vera Extract
Tea Tree Oil
Clove Bud Oil
Lavender Oil
Jojoba Oil
Manuka Oil
Peppermint Oil
OREGANO LEAF OIL
PROPOLIS
ALMOND OIL
.ALPHA.-TOCOPHEROL ACETATE (Vitamin E)
Purified Water

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
85578-003-01TEGASOLVE TOENAIL FUNGUS TREATMENT30 mL in 1 BOTTLELIQUID301
85578-003-01TEGASOLVE TOENAIL FUNGUS TREATMENT1 in 1 BOXLIQUID11

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85578-00385578-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
JOJOBA OIL724GKU717MIACT
UNDECYLENIC ACIDK3D86KJ24NACTIB
ALMOND OIL66YXD4DKO9IACT
PROPOLIS WAX6Y8XYV2NOFIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
MANUKA OILM6QU9ZUH2XIACT
LAVENDER OILZBP1YXW0H8IACT
CLOVE OIL578389D6D0IACT
OREGANO LEAF OIL7D0CGR40U1IACT
PEPPERMINT OILAV092KU4JHIACT
ALOE VERA LEAFZY81Z83H0XIACT
TEA TREE OILVIF565UC2GIACT

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
TEGASOLVE TOENAIL FUNGUS TREATMENTUNDECYLENIC ACID 25%Zhengzhou Hangrui Network Technology Co., Ltd.375b0515-1b1f-23b8-e063-6294a90a9d682025-06-12WarningsExact identifier
ndc (package): 85578-003-01
ndc (product): 85578-003
ndc11 (package): 85578000301
spl id: 375b0515-1b20-23b8-e063-6294a90a9d68
spl set id: 375b0515-1b1f-23b8-e063-6294a90a9d68

Reported adverse events (FAERS/openFDA)#

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