GEMACHLICH ZUHAUSE FUNGAL NAIL REVITALIZER liquid

Gemachlich ZuHause Fungal Nail Revitalizer by

Drug Labeling and Warnings

Gemachlich ZuHause Fungal Nail Revitalizer by is a Otc medication manufactured, distributed, or labeled by Guangdong Quadrant Ecological Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Undecylenic Acid 11%

Purpose

For Healthier and Stronger Nails.

Use

For superficial skin fungal infections, skin candidiasis, onychomycosis.

Warnings

.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

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

When Using

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

Stop Use

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

Ask Doctor

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

Keep Out Of Reach Of Children

Keep out of reach of Children.

Directions

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

· 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

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

INGREDIENTS AND APPEARANCE

GEMACHLICH ZUHAUSE FUNGAL NAIL REVITALIZER 
gemachlich zuhause fungal nail revitalizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76986-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	11 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
HYDROXYPROPYLCELLULOSE (UNII: 9XZ8H6N6OH)
ZANTHOXYLUM BUNGEANUM FRUIT (UNII: 3CIP16A418)
GLYCOLIC ACID (UNII: 0WT12SX38S)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SALICYLIC ACID (UNII: O414PZ4LPZ)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
UREA (UNII: 8W8T17847W)
MENTHOL (UNII: L7T10EIP3A)
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76986-007-01	3 in 1 BOX	06/10/2025
1		4 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 76986-007-02	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/10/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	06/10/2025

Labeler - Guangdong Quadrant Ecological Technology Co., Ltd. (554532634)

Establishment
Name	Address	ID/FEI	Business Operations
Guangdong Quadrant Ecological Technology Co., Ltd.		554532634	manufacture(76986-007)