FDA.reportPublic FDA data

Undecylenic Acid

Manufacturer
Family Dollar Services Inc.
Effective date
2017-12-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:53:29

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

FAMILY WELLNESS

MAXIMUM STRENGTH

Anti- Fungal Nail Pen

Undecylenic Acid 25%

Eliminates Fungus on Fingers, Toes and Around Nails

  • Pre- fikllled with applicator brush
  • Covenient and Easy to use
  • Dries Quickly 
  • Non - oily, clean Formula
0.05 FL. OZ (1.7 mL)

Family Dollar_Family Wellness - Anti-Fungal Nail Solution Pen_53-091FD-01.jpgFamily Dollar_Family Wellness - Anti-Fungal Nail Solution Pen_53-091FD-01.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55319-055-172021-07-23C16284748780-1c7ccaba7-244b-fd44-e053-dadaa90aa01bAntifungal Nail Pen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-055-17Undecylenic Acid1.7 mL in 1 APPLICATORLIQUID1.71

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-055UNDECYLENIC ACID (ANTIFUNGAL PEN) LIQUID [FAMILY DOLLAR SERVICES INC.]1Legacy NDC, 1 package rows20171215_01a3eb23-bea8-474d-aaf8-aabd23574710.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
55319-05555319-055-17

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
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
e9cc4be5-2fe6-43b5-894b-f01ce4ff6b0401a3eb23-bea8-474d-aaf8-aabd235747102017-12-15WarningsExact identifier
spl id: e9cc4be5-2fe6-43b5-894b-f01ce4ff6b04
spl set id: 01a3eb23-bea8-474d-aaf8-aabd23574710

Reported adverse events (FAERS/openFDA)#

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