SOOTHESENSE TOENAIL FUNGUS TREATMENT- undecylenic acid liquid

SootheSense Toenail Fungus Treatment by

Drug Labeling and Warnings

SootheSense Toenail Fungus Treatment 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 25%

PURPOSE

Antifungal

INDICATIONS & USAGE

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

WARNINGS

For external use only.

DO NOT USE

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

WHEN USING

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

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & 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

INACTIVE INGREDIENT

ALCOHOL
WATER
UREA
PROPYLENE GLYCOL
SALICYLIC ACID
MENTHOL
HYDROXYPROPYLCELLULOSE
ZANTHOXYLUM BUNGEANUM FRUIT EXTRACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL
DISODIUM EDTA
GLYCOLIC ACID

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOOTHESENSE TOENAIL FUNGUS TREATMENT 
undecylenic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76986-027
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	0.25 g  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76986-027-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/10/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	03/10/2026

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

Establishment
Name	Address	ID/FEI	Business Operations
Guangdong Quadrant Ecological Technology Co., Ltd.		554532634	manufacture(76986-027)