FDA.reportPublic FDA data

Antifungal Pen

Manufacturer
XF Agencija Limited
Effective date
2025-01-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:53:46

Label at a glance#

ProductAntifungal Pen
Active ingredientUNDECYLENIC ACID
Label structure14 sections

Indications and uses

For the treatment of athlete's foot, jock itch, and ringworm.

Dosage and administration

■ Read all warnings and directions ■ Use only as directed ■ Clean the affected area with soap and water and dry thoroughly ■ Remove cap from pen ■ Twist the base of the pen, with brush pointing downward, until product dispenses ■ Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor ■ For athlete's foot, pay special attention to spaces between the toes;...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid 25%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

For the treatment of athlete's foot, jock itch, and ringworm.

Warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

When using this product avoid contact with eyes.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation occurs or there is no improvement within 4 weeks.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

■ Read all warnings and directions

■ Use only as directed
■ Clean the affected area with soap and water and dry thoroughly

■ Remove cap from pen

■ Twist the base of the pen, with brush pointing downward, until product dispenses

■ Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor

■ For athlete's foot, pay special attention to spaces between the toes; wear well-fitting,ventilated shoe, and change shoes and socks at least once daily.

Other information

SPL UNCLASSIFIED SECTION

■ Store at 15°-30°C (59° - 86°F)
■ Keep cap on pen when not in use

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Vera Extract, Sweet Almond Oil, Jojoba Oil, Tea Tree Oil, Manuka Oil, Clove Bud Oil, Lavender Oil, Oregano Oil, Peppermint Oil, Propolis Extract, Tocopheryl Acetate (Vitamin E).

NDC 85210-001-01 (01 Pen 3 mL)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1 PEN WITH BLEED.jpg1 PEN WITH BLEED.jpg

NDC 85210-001-02 (03 Pens 9 mL)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3 PENS WITH BLEED3 PENS WITH BLEED

NDC 85210-001-03 (06 Pens 18 mL)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

6 PENS WITH BLEED6 PENS WITH BLEED

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998329undecylenic acid 25 % Topical SolutionPSN1
998329undecylenic acid 250 MG/ML Topical SolutionSCD1
998329undecylenic acid 25 % Topical SolutionSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85210-001-01Antifungal Pen1 in 1 CARTONLIQUID11
85210-001-01Antifungal Pen3 mL in 1 APPLICATORLIQUID31
85210-001-02Antifungal Pen3 mL in 1 APPLICATORLIQUID31
85210-001-02Antifungal Pen3 in 1 CARTONLIQUID31
85210-001-03Antifungal Pen6 in 1 CARTONLIQUID61
85210-001-03Antifungal Pen3 mL in 1 APPLICATORLIQUID31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85210-001ANTIFUNGAL PEN (UNDECYLENIC ACID 25%) LIQUID [XF AGENCIJA LIMITED]1Current NDC, 6 package rows20250129_a15d4512-0fc6-424f-9dd3-ab433d9b7a26.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85210-00185210-001-01, 85210-001-02, 85210-001-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
UNDECYLENIC ACIDK3D86KJ24NACTIB
ALOE VERA LEAFZY81Z83H0XIACT
ALMOND OIL66YXD4DKO9IACT
JOJOBA OIL724GKU717MIACT
TEA TREE OILVIF565UC2GIACT
MANUKA OILM6QU9ZUH2XIACT
CLOVE OIL578389D6D0IACT
LAVENDER OILZBP1YXW0H8IACT
OREGANO LEAF OIL7D0CGR40U1IACT
PEPPERMINT OILAV092KU4JHIACT
PROPOLIS WAX6Y8XYV2NOFIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antifungal PenUNDECYLENIC ACID 25%XF Agencija Limiteda15d4512-0fc6-424f-9dd3-ab433d9b7a262025-01-27WarningsExact identifier
ndc (package): 85210-001-01
ndc (package): 85210-001-03
ndc (package): 85210-001-02
ndc (product): 85210-001
ndc11 (package): 85210000103
ndc11 (package): 85210000101
ndc11 (package): 85210000102
spl id: 9e2dd8ab-e1b8-43fd-b156-f3788c591db4
spl set id: a15d4512-0fc6-424f-9dd3-ab433d9b7a26

Reported adverse events (FAERS/openFDA)#

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