FDA.reportPublic FDA data

Human Science Antifungal Foot Care

Manufacturer
HUMAN SCIENCE, LLC
Effective date
2023-11-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:58:54

Label at a glance#

ProductHuman Science Antifungal Foot Care
Active ingredientUNDECYLENIC ACID
Label structure7 sections

Indications and uses

For effective relief of itching, burning and cracking.

Dosage and administration

Wash affected area well, and dry thoroughly. Supervise, children in the use of this product. For arthlete's foot:pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change socks at least once daily. Use 1-2 times daily or as directed by physician. Use daily for 4 weeks; if condition persists longer, ask a doctor. This product is not effective on the scalp or nails.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid 25.00%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses:

INDICATIONS & USAGE SECTION

  • For effective relief of itching, burning and cracking.

Warnings:

WARNINGS SECTION

  • For external use only.

Do not use

OTC - DO NOT USE SECTION

on children under 2 years of age except under the supervision of a doctor.

When using this product

OTC - WHEN USING SECTION

avoid contact with the eyes.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

-Irritation occurs.

-There is no improvement within 4 weeks.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Wash affected area well, and dry thoroughly.
  • Supervise, children in the use of this product.
  • For arthlete's foot:pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change socks at least once daily.
  • Use 1-2 times daily or as directed by physician.
  • Use daily for 4 weeks; if condition persists longer, ask a doctor.
  • This product is not effective on the scalp or nails.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Dimethyl Sulfoxid (DMSO), Ethoxydigilcol, Eugenia Caryophyllus (Clove) Bud oil, Helianthus Annuus (Sunflower) Oil, Isopropyl Myristate, Melaleuca Alternifolia (Tea Tree) Oil, Methyl Salicylate, Thymus Vulgaris (Thyme) Extract.

Other Information:

SPL UNCLASSIFIED SECTION

Store between 20° to 30°C (68° to 86°F)

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998329undecylenic acid 25 % Topical SolutionPSN3
998329undecylenic acid 250 MG/ML Topical SolutionSCD3
998329undecylenic acid 25 % Topical SolutionSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71356-156-01Human Science Antifungal Foot Care30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71356-156HUMAN SCIENCE ANTIFUNGAL FOOT CARE (UNDECYLENIC ACID) LIQUID [HUMAN SCIENCE, LLC]3Current NDC, Legacy NDC, 1 package rows20231106_26b2519b-7d7b-4b33-b5d6-a41fe6f73538.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71356-15671356-156-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHYL SULFOXIDEYOW8V9698HIACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
CLOVE OIL578389D6D0IACT
SUNFLOWER OIL3W1JG795YIIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT
METHYL SALICYLATELAV5U5022YIACT
THYMECW657OBU4NIACT
UNDECYLENIC ACIDK3D86KJ24NACTIB

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
Human Science Antifungal Foot CareUNDECYLENIC ACIDHUMAN SCIENCE, LLC26b2519b-7d7b-4b33-b5d6-a41fe6f735382023-11-05WarningsExact identifier
ndc (package): 71356-156-01
ndc (product): 71356-156
ndc11 (package): 71356015601
spl id: 097478f1-9b38-b749-e063-6394a90a9977
spl set id: 26b2519b-7d7b-4b33-b5d6-a41fe6f73538

Reported adverse events (FAERS/openFDA)#

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