FDA.reportPublic FDA data

Undecylenic Acid

Manufacturer
Chain Drug Marketing Association
Effective date
2023-01-25
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:39:03

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 soreness discomfort which may accompany these conditions

Dosage and administration

Read all warnings 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 affecter area twice daily (morning and night) or as directed by a doctor 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...

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
  • soreness
  • discomfort which may accompany these conditions

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 warnings 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 affecter area twice daily (morning and night) or as directed by a doctor
  • 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 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 conditions persists longer, consult a doctor
  • this product is not effective on the scalp or nails

​Other information

OTHER SAFETY INFORMATION

  • store at room temperature 15°-30°C (59° - 86°F)
  • 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 1-248-449-9300

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QC

Quality Choice

Maximum Strength

​Antifungal Pen

​Fungus Treatment

​25% Undecylenic Acid​

Eliminates Fungus on Fingers, Toes and Around Nails

Pre-Filled Pen with Brush Applicator

Convenient & Easy to Use

Dries Quickly

Non-Oily, Clear Formula

.05 FL OZ (1.7 mL)

QC Antifungal Pen Box.jpgQC Antifungal Pen Box.jpg

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
UNDECYLENIC ACIDACTIVE INGREDIENTK3D86KJ24N1
UNDECYLENIC ACIDACTIVE MOIETYK3D86KJ24N1
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63M1

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
63868-12063868-120-17

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
ISOPROPYL PALMITATE8CRQ2TH63MIACT
UNDECYLENIC ACIDK3D86KJ24NACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 8 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MLOTION / TOPICAL5 %w/wExact identifier — unii candidate
8 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MFILM / TRANSDERMAL2 mgExact identifier — unii candidate
8 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MFILM, EXTENDED RELEASE / TRANSDERMAL187.5 mgExact identifier — unii candidate
8 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MOINTMENT / TOPICALNAExact identifier — unii candidate
8 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MAEROSOL, SPRAY / TOPICAL397 mgExact identifier — unii candidate
8 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MAEROSOL / TOPICAL397 mgExact identifier — unii candidate
8 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MGEL / TOPICALNAExact identifier — unii candidate
8 equally ranked IID candidates
ISOPROPYL PALMITATEISOPROPYL PALMITATE8CRQ2TH63MCREAM / TOPICAL112 mgExact identifier — unii candidate
8 equally ranked IID candidates

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
11462fe7-c4f6-5932-e063-6294a90a68f955833497-b3ef-47bd-8d91-d991aa5272c12024-02-13WarningsExact identifier
spl set id: 55833497-b3ef-47bd-8d91-d991aa5272c1

Reported adverse events (FAERS/openFDA)#

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