TOENAIL FUNGUS PEN PREVENTATIVE- undecylenic acid spray

Drug Labeling and Warnings

Drug Details [pdf]

INACTIVE INGREDIENT

AQUA 54.31%
aluminum chloride 0.1%
Berberis Root Extract 0.05%
Dipotassium Glycyrrhizinate 0.05%
Glycyrrhiza Glabra (Licorice) Root Extract 0.05%
Allantoin 2%
menthol 1%
Propylene glycol 5%
Butylene Glycol 5%
Glycerol polyether-26 0.05%
Sodium Hyaluronate 0.05%
ethanol 5%
Methyl glucosinol polyether-20 0.05%
sodium hydroxide 0.02%
Sorbic AcidPotassium Salt 0.2%
Sodium Pyrosulfite 0.02%

DOSAGE & ADMINISTRATION

Shake can well and spray a thin layer of the product to the feet once or twice daily(morning and/or night)

WARNINGS

For external use only. Avoid contact with eyes.

ACTIVE INGREDIENT

Undecylenic Acid 25%
Miconazole nitrate 2%

KEEP OUT OF REACH OF CHILDREN

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

PURPOSE

Inhibit fungi Eliminates Foot Odor

INDICATIONS & USAGE

Helps prevent most athlete's foot fungus with daily use.Treats nail fungus and skin' fungal infections.

Shake can well and spray a thin layer of the product to the feet once or twice daily(morning and/or night)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOENAIL FUNGUS PEN PREVENTATIVE 
undecylenic acid spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84896-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	2 g  in 100 mL
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	25 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
AQUA (UNII: 059QF0KO0R)	54.31 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84896-010-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/26/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	05/26/2026

Labeler - Guangzhou Mizi Biotechnology Co., Ltd. (418001649)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Mizi Biotechnology Co., Ltd.		418001649	manufacture(84896-010)