ANTIFUNGAL PEN- undecylenic acid liquid

Drug Labeling and Warnings

Drug Details [pdf]

INACTIVE INGREDIENT

water 49..8%
glycerol 3%
Hansheng rubber 0.2%
glutinous rehmannia 5%
kuh-seng 5%
white willow 5%
acetic acid 1%
keratin 1%
garden balsam 1%
Dittany 1%
pseudo-ginseng 1%
tea tree oil 2%

DOSAGE & ADMINISTRATION

Apply twice daily
Flenailsevery2-3 days.
Net Weight:15 mL(3mLx5 Pens)

WARNINGS

Avoid contact with eyes. Stop use if irritation occurs.
Keep out of reach of children.

ACTIVE INGREDIENT

Undecylenic Acid 25%

KEEP OUT OF REACH OF CHILDREN

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

PURPOSE

Treats nailfungus

INDICATIONS & USAGE

Treats nail fungus and skin fungal infections.

Apply twice daily
File nails every 2-3 days.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTIFUNGAL PEN 
undecylenic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84896-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	25 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	49.8 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84896-008-01	15 mL in 1 BAG; 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(84896-008)