FDA.reportPublic FDA data

Gembooxt Nail Fungus Solution

Manufacturer
Guangdong Quadrant Ecological Technology Co., Ltd.
Effective date
2025-12-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:19:19

Label at a glance#

ProductGembooxt Nail Fungus Solution
Active ingredientUNDECYLENIC ACID
Label structure14 sections

Dosage and administration

• 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.

Storage and handling

•Store at 20°-25C(68°-77°F). •Protect from light. •Keep container tightly closed. •See bottom of package for lot number and expiration date.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid (11%)

Purpose

OTC - PURPOSE SECTION

Antifungal

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION


• For external use only.

Do not use

OTC - DO NOT USE SECTION

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

When Using

OTC - WHEN USING SECTION

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

Stop Use

OTC - STOP USE SECTION

• Stop use and ask a doctor if irritation occurs or there is no improvement within 4 weeks.

Ask Doctor

OTC - ASK DOCTOR SECTION

• Stop use and ask a doctor if irritation occurs or there is no improvement within 4 weeks.

Keep Out Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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.

Other information

STORAGE AND HANDLING SECTION

•Store at 20°-25C(68°-77°F).
•Protect from light.
•Keep container tightly closed.
•See bottom of package for lot number and expiration date.

Inactive ingredients

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

Questions

OTC - QUESTIONS SECTION

Tel.400-055-8876

Manufacturerd: Guangdong Quadrant Ecological Technology Co.,Ltd.
Address: Building B, General Plant, North Shanfen Road, West Songshan Road,Longhu,Shantou,Guangdong,China

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1122

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1099259undecylenic acid 11 % Topical SolutionPSN1
1099259undecylenic acid 110 MG/ML Topical SolutionSCD1
1099259undecylenic acid 11 % Topical SolutionSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-136977863764162GTIN-13: 6977863764162
EAN-13: 6977863764162
GTIN storage (14 digits): 06977863764162		Pack.jpg, Pack2.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76986-016-01Gembooxt Nail Fungus Solution3 in 1 BOXLIQUID31
76986-016-01Gembooxt Nail Fungus Solution4 mL in 1 TUBELIQUID41
76986-016-02Gembooxt Nail Fungus Solution30 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
76986-01676986-016-01, 76986-016-02

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

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
Gembooxt Nail Fungus SolutionGEMBOOXT NAIL FUNGUS SOLUTIONGuangdong Quadrant Ecological Technology Co., Ltd.44f5c1bc-decf-beef-e063-6394a90ab5622025-12-02WarningsExact identifier
ndc (package): 76986-016-01
ndc (package): 76986-016-02
ndc (product): 76986-016
ndc11 (package): 76986001602
ndc11 (package): 76986001601
spl id: 44f5c1bc-ded0-beef-e063-6394a90ab562
spl set id: 44f5c1bc-decf-beef-e063-6394a90ab562

Reported adverse events (FAERS/openFDA)#

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