FDA.reportPublic FDA data

Gemachlich ZuHause Fungal Nail Revitalizer

Manufacturer
Guangdong Quadrant Ecological Technology Co., Ltd.
Effective date
2025-06-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:02:53

Label at a glance#

ProductGemachlich ZuHause Fungal Nail Revitalizer
Active ingredientUNDECYLENIC ACID
Label structure13 sections

Dosage and administration

For external use only. Use the brush to apply a layer ofliquid directly to the affected nail(s),2-3 times dailyfor 2-4 weeks.

Storage and handling

· If you are using other drugs, please consult your physician or pharmacist before using this product. · Shielded from light, sealed, stored in a cool place (not more than 20°C).

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid 11%

Purpose

OTC - PURPOSE SECTION

For Healthier and Stronger Nails.

Use

INDICATIONS & USAGE SECTION

For superficial skin fungal infections, skin candidiasis, onychomycosis.

Warnings

WARNINGS SECTION

.For external use only.
.Contraindicated for children, pregnant and lactating women.
.Prohibited for those who are allergic to this product. Allergic persons should be cautious.
.Prohibit the use of this product when the properties of the product have changed.

Do not use

OTC - DO NOT USE SECTION

Do not use if there is any burning sensation, redness or swelling at the site of application.

When Using

OTC - WHEN USING SECTION

When Using this product, avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.

Stop Use

OTC - STOP USE SECTION

Stop Using and ask a doctor if irritation or redness develops and lasts.

Ask Doctor

OTC - ASK DOCTOR SECTION

In case of accidental ingestion, get medical help or contact a poison control center immediately.

Keep Out Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of Children.

Directions

DOSAGE & ADMINISTRATION SECTION

For external use only. Use the brush to apply a layer ofliquid directly to the affected nail(s),2-3 times dailyfor 2-4 weeks.

Other information

STORAGE AND HANDLING SECTION

· If you are using other drugs, please consult your physician or pharmacist before using this product.
· Shielded from light, sealed, stored in a cool place (not more than 20°C).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol, Water, Urea, Propylene Glycol, Salicylic Acid, Menthylum, Hydroxypropylcellulose, Zanthoxylum Bungeanum Fruit
Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Disodium EDTA, Glycolic Acid

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

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

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
76986-007-01Gemachlich ZuHause Fungal Nail Revitalizer3 in 1 BOXLIQUID31
76986-007-01Gemachlich ZuHause Fungal Nail Revitalizer4 mL in 1 TUBELIQUID41
76986-007-02Gemachlich ZuHause Fungal Nail Revitalizer30 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
76986-00776986-007-01, 76986-007-02

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
ALCOHOL3K9958V90MIACT
HYDROXYPROPYLCELLULOSE9XZ8H6N6OHIACT
ZANTHOXYLUM BUNGEANUM FRUIT3CIP16A418IACT
GLYCOLIC ACID0WT12SX38SIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SALICYLIC ACIDO414PZ4LPZIACT
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT
UREA8W8T17847WIACT
MENTHOLL7T10EIP3AIACT
UNDECYLENIC ACIDK3D86KJ24NACTIB
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF 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
Gemachlich ZuHause Fungal Nail RevitalizerGEMACHLICH ZUHAUSE FUNGAL NAIL REVITALIZERGuangdong Quadrant Ecological Technology Co., Ltd.37332cdf-7171-42cc-e063-6394a90a0fcf2025-06-10WarningsExact identifier
ndc (package): 76986-007-01
ndc (package): 76986-007-02
ndc (product): 76986-007
ndc11 (package): 76986000701
ndc11 (package): 76986000702
spl id: 37332cdf-7172-42cc-e063-6394a90a0fcf
spl set id: 37332cdf-7171-42cc-e063-6394a90a0fcf

Reported adverse events (FAERS/openFDA)#

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