87571-001 ANTIFUNGAL PEN

Manufacturer: Hanyang Qisheng (Shenzhen) Technology Co., Ltd.
Effective date: 2026-04-02
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 01:52:35

Label at a glance#

ProductANTIFUNGAL PEN

Active ingredientTERBINAFINE HYDROCHLORIDE, UNDECYLENIC ACID

Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

TERBINAFINE HYDROCHLORIDE 1%
UNDECYLENIC ACID 25%

OTC - PURPOSE SECTION

Antifungal

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For externaluse only.

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

When using this product avoid contact with the eyes.

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2740011	terbinafine hydrochloride 1 % / undecylenic acid 25 % Topical Solution	PSN	1
2740011	terbinafine hydrochloride 10 MG/ML / undecylenic acid 250 MG/ML Topical Solution	SCD	1
2740011	terbinafine hydrochloride 1 % / undecylenic acid 25 % Topical Solution	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
TERBINAFINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
55a24767-1759-5f6a-8888-ea4aa0adac21	Product name	1	20140508
db9701af-cb4f-b8ba-d282-6bc5b6b7c467	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
87571-001-01	ANTIFUNGAL PEN	5 mL in 1 BOTTLE	LIQUID	5	1
87571-001-01	ANTIFUNGAL PEN	3 in 1 PACKAGE	LIQUID	3	1
87571-001-02	ANTIFUNGAL PEN	6 in 1 PACKAGE	LIQUID	6	1
87571-001-02	ANTIFUNGAL PEN	5 mL in 1 BOTTLE	LIQUID	5	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

ANTIFUNGAL PEN
UNDECYLENIC ACID, TERBINAFINE HYDROCHLORIDE
TOCOPHEROL
TERBINAFINE HYDROCHLORIDE
TERBINAFINE
BISABOLOL
CAPRYLIC/CAPRIC TRIGLYCERIDE
TEA TREE OIL
ETHYLHEXYL PALMITATE
SQUALANE
UNDECYLENIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
87571-001	87571-001-01, 87571-001-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
TOCOPHEROL	R0ZB2556P8	IACT
TERBINAFINE HYDROCHLORIDE	012C11ZU6G	ACTIB
BISABOLOL	24WE03BX2T	IACT
CAPRYLIC/CAPRIC TRIGLYCERIDE	C9H2L21V7U	IACT
TEA TREE OIL	VIF565UC2G	IACT
ETHYLHEXYL PALMITATE	2865993309	IACT
SQUALANE	GW89575KF9	IACT
UNDECYLENIC ACID	K3D86KJ24N	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ANTIFUNGAL PEN	UNDECYLENIC ACID, TERBINAFINE HYDROCHLORIDE	Hanyang Qisheng (Shenzhen) Technology Co., Ltd.	4e85f338-ffd7-85b1-e063-6294a90a3c87	2026-04-02	Warnings	Exact identifier ndc (package): 87571-001-02 ndc (package): 87571-001-01 ndc (product): 87571-001 ndc11 (package): 87571000102 ndc11 (package): 87571000101 spl id: 4e85f338-ffd8-85b1-e063-6294a90a3c87 spl set id: 4e85f338-ffd7-85b1-e063-6294a90a3c87

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.