FDA.reportPublic FDA data

Undecylenic Acid

Manufacturer
Chemco Corporation
Effective date
2023-12-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:03:18

Label at a glance#

ProductUndecylenic Acid
Active ingredientUNDECYLENIC ACID
Label structure11 sections

Indications and uses

Cures most athlete’s foot (tinea pedis) and ringworm (tinea corporis). Relieves itching, scaling, cracking, burning, and redness.

Dosage and administration

Wash affected area and dry thoroughly. Apply a thin layer of the product over the affected area (around the nails and underneath nail tips) twice daily or as directed by a doctor. 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, us...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

​Undecylenic Acid 25%

OTC - PURPOSE SECTION

Antifungal

USES:

INDICATIONS & USAGE SECTION

Cures most athlete’s foot (tinea pedis) and ringworm (tinea corporis).

Relieves itching, scaling, cracking, burning, and redness.

WARNINGS SECTION

For external use only.

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

Avoid contact with eyes. If contact occurs, rinse thoroughly with water

EXTREMELY FLAMMABLE:

SAFE HANDLING WARNING SECTION

Keep away from fire or flame.

STOP USE AND ASK A DOCTOR IF

OTC - STOP USE SECTION

Irritation occurs or if there is no improvement within 4 weeks.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Wash affected area and dry thoroughly. Apply a thin layer of the product over the affected area (around the nails and underneath nail tips) twice daily or as directed by a doctor. 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:

GENERAL PRECAUTIONS SECTION

Store at room temperature 15° - 30°C (59° - 86°F)

INACTIVE INGREDIENT SECTION

Isopropyl Alcohol, Water (Aqua), Tocopheryl Acetate, DMDM Hydantoin, Melaleuca Alternifolia Leaf Oil.

PRONAIL FUNGUS KILLER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FUNGUS KILLERFUNGUS KILLER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998329undecylenic acid 25 % Topical SolutionPSN4
998329undecylenic acid 250 MG/ML Topical SolutionSCD4
998329undecylenic acid 25 % Topical SolutionSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49283-025-052020-01-31C16284748780-19d75b9cf-df49-f424-e053-dadaa90a57ce49283-025-05

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49283-025-05Undecylenic Acid15 mL in 1 BOTTLE, WITH APPLICATORLIQUID154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49283-025UNDECYLENIC ACID LIQUID [CHEMCO CORPORATION]4Current NDC, 1 package rows20231206_7391b53f-5567-1f45-e053-2991aa0a4fce.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49283-02549283-025-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
DMDM HYDANTOINBYR0546TOWIACT
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
UNDECYLENIC ACIDK3D86KJ24NACTIB
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT

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
Undecylenic AcidUNDECYLENIC ACIDChemco Corporation7391b53f-5567-1f45-e053-2991aa0a4fce2023-12-05WarningsExact identifier
ndc (package): 49283-025-05
ndc (product): 49283-025
ndc11 (package): 49283002505
spl id: 0bc72bd8-1f30-b01c-e063-6394a90a77ea
spl set id: 7391b53f-5567-1f45-e053-2991aa0a4fce

Reported adverse events (FAERS/openFDA)#

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