FDA.reportPublic FDA data

Undecylenic Acid

Manufacturer
Target Corporation
Effective date
2017-12-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:54:21

Label at a glance#

ProductUndecylenic Acid
Active ingredientUndecylenic Acid
Label structure9 sections

Indications and uses

For the cure of most tinea pedis (athlete's foot) and tinea corporis (ringworm) For relief of: itching burning redness irritation scaling discomfort which may accompany these conditions soreness

Dosage and administration

Read all warning and directions. Use only as directed. clean the affected area and dry thoroughly twist pen base with 3 clicks to saturate brush apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by the doctor the brush applicator allows for easy application under nails and surrounding cuticle area supervise children in the use of this product for athlete's foot...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Undecylenic acid 25%w/w

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

For the cure of most tinea pedis (athlete's foot) and tinea corporis (ringworm)
For relief of:

  • itching
  • burning
  • redness
  • irritation
  • scaling
  • discomfort which may accompany these conditions
  • soreness

Warnings

WARNINGS SECTION

For external use only

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

consult a healthcare professional before use.

Do not use

OTC - DO NOT USE SECTION

on children 2 years of age unless directed by a doctor. 

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes

Use only as directed

INSTRUCTIONS FOR USE SECTION

by a doctor on persons with highly sensitive skin.

Stop use and consult a doctor if

OTC - STOP USE SECTION

  • there is no improvement within 4 weeks
  • irritation occurs

Keep out of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If accidental ingestion occurs, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Read all warning and directions. Use only as directed.

  • clean the affected area and dry thoroughly
  • twist pen base with 3 clicks to saturate brush
  • apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by the doctor
  • the brush applicator allows for easy application under nails and surrounding cuticle area
  • supervise children in the use of this product
  • for athlete's foot: pay special attention to spaces between the toes
  • wear well- fitting, ventilated shoes, and change shoes and socks at least once daily
  • for athlete's foot and ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.
  • this product is not effective on the scalp or nails

Other information

OTHER SAFETY INFORMATION

  • store at room temperature 150 - 300C (590 - 860F)
  • protect from freezing. if freezing occurs, warm to room temperature.
  • keep tightly closed when not in use

Inactive ingredient

INACTIVE INGREDIENT SECTION

isopropyl palmitate

Questions?

OTC - QUESTIONS SECTION

Call 1-866-964-0939

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

maximum strength 

antifungal nail pen

25% undecylenic Acid

eleminates fungus on fingers, toes and around nails

prefilled applicator pen brush

dries quickly

0.10 Fl. OZ (3 mL)

up&up_Antifungal Nail Pen_Box_0.10FLOZ-01.jpgup&up_Antifungal Nail Pen_Box_0.10FLOZ-01.jpgup&up_Antifungal Nail Pen_0.10FLOZ-01.jpgup&up_Antifungal Nail Pen_0.10FLOZ-01.jpg

up&up_Antifungal Nail Pen_Box_0.10FLOZ-01.jpgup&up_Antifungal Nail Pen_Box_0.10FLOZ-01.jpgup&up_Antifungal Nail Pen_0.10FLOZ-01.jpgup&up_Antifungal Nail Pen_0.10FLOZ-01.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11673-634-302021-07-23C16284748780-1c7ccaba7-2445-fd44-e053-dadaa90aa01bAntifungal Nail Pen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-634-30Undecylenic Acid3 mL in 1 APPLICATORLIQUID33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-634UNDECYLENIC ACID (ANTIFUNGAL PEN) LIQUID [TARGET CORPORATION]3Legacy NDC, 1 package rows20180201_e9f63585-0f48-4ec0-9861-e9c5782cec60.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11673-63411673-634-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
Undecylenic AcidK3D86KJ24NACTIB
ISOPROPYL PALMITATE8CRQ2TH63MIACT

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
5cbeacb6-e128-45e7-bb60-12bec70ce3b4e9f63585-0f48-4ec0-9861-e9c5782cec602017-12-01WarningsExact identifier
spl id: 5cbeacb6-e128-45e7-bb60-12bec70ce3b4
spl set id: e9f63585-0f48-4ec0-9861-e9c5782cec60

Reported adverse events (FAERS/openFDA)#

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