ANTIFUNGAL PEN- undecylenic acid, terbinafine hydrochloride liquid

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

TERBINAFINE HYDROCHLORIDE 1%
UNDECYLENIC ACID 25%

PURPOSE

Antifungal

INDICATIONS & USAGE

For the effective treatment of nail fungus,discoloration, thickening,splitting,crumbling and brittleness.

WARNINGS

For externaluse only.

DO NOT USE

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

WHEN USING

When using this product avoid contact with the eyes.

STOP USE

Stop use and ask a doctor if irritation occurs,discontinue use and consulta doctor.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Use twice a day for 4 weeks.

For initial use, soak the affected nail in warm water to soften it. Gentlyf ile thenail to make it thinner and remove dirt, being cautious not to harm the nail bed.For best results f ile nails every 2-3 days.
Rotate clockwise, after the solution f lows out,apply the solution to the affected area.

INACTIVE INGREDIENT

ETHYLHEXYL PALMITATE
SQUALANE
CAPRYLIC/CAPRIC TRIGLYCERIDE
BISABOLOL
TOCOPHEROL
TEA TREE OIL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTIFUNGAL PEN 
undecylenic acid, terbinafine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87571-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TERBINAFINE HYDROCHLORIDE (UNII: 012C11ZU6G) (TERBINAFINE - UNII:G7RIW8S0XP)	TERBINAFINE HYDROCHLORIDE	1 g  in 100 mL
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	25 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)
BISABOLOL (UNII: 24WE03BX2T)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
TEA TREE OIL (UNII: VIF565UC2G)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
SQUALANE (UNII: GW89575KF9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87571-001-01	3 in 1 PACKAGE	04/03/2026
1		5 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 87571-001-02	6 in 1 PACKAGE	04/03/2026
2		5 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	04/03/2026

Labeler - Hanyang Qisheng (Shenzhen) Technology Co., Ltd. (568683582)

Establishment
Name	Address	ID/FEI	Business Operations
Hanyang Qisheng (Shenzhen) Technology Co., Ltd.		568683582	manufacture(87571-001)