FDA.reportPublic FDA data

FUNGLARA Anti Fungal

Manufacturer
FUNGLARA LLC | Pure Source, LLC
Effective date
2025-08-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:11:23

Label at a glance#

ProductFUNGLARA Anti Fungal
Active ingredientUNDECYLENIC ACID
Label structure8 sections

Indications and uses

Proven effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis). Helps prevent most athlete's foot with daily use. For effective relief of itching, burning and cracking.

Dosage and administration

• Clean affected areas with soap and warm water and dry thoroughly. • Apply a thin layer of Funglara over affected area twice daily (morning and night) or as directed by a doctor. • Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. • For athlete's foot pay special attention to spaces between the toes. • For athlete's foot and ringworm, use daily for 4 weeks. • To prevent athlete'...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid 25.0%

Purpose

OTC - PURPOSE SECTION

Anti-fungal

Uses:

INDICATIONS & USAGE SECTION

  • Proven effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis).
  • Helps prevent most athlete's foot with daily use.
  • 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 unless directed by 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

In case of accidental ingestion, contact a physician, emergency medical care facility or Poison Control Center immediately for advice.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions:

DOSAGE & ADMINISTRATION SECTION

• Clean affected areas with soap and warm water and dry thoroughly. • Apply a thin layer of Funglara over affected area twice daily (morning and night) or as directed by a doctor. • Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. • For athlete's foot pay special attention to spaces between the toes. • For athlete's foot and ringworm, use daily for 4 weeks. • To prevent athlete's foot, apply once
or twice daily (morning and/or night). If condition persists longer, consult a doctor. • This product is not effective on the scalp or nails.

Other information:

SPL UNCLASSIFIED SECTION

Protect the product in this container from excessive heat and direct sun.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Acetic Acid, Aloe Barbadensis Leaf Juice, Glycerin, Glycyrrhiza Glabra (Licorice) Root Extract, Isopropyl Alcohol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Thymus Vulgaris (Thyme) Extract, Water (Aqua)

Questions?

OTC - QUESTIONS SECTION

Call: 844-638-6487
Email: help@funglara.com
Visit: www.funglara.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998329undecylenic acid 25 % Topical SolutionPSN1
998329undecylenic acid 250 MG/ML Topical SolutionSCD1
998329undecylenic acid 25 % Topical SolutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87028-876-00FUNGLARA Anti Fungal15 mL in 1 BOTTLESOLUTION151

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
87028-87687028-876-00

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
ACETIC ACIDQ40Q9N063PIACT
ALOE VERA LEAF JUICERUE8E6T4NBIACT
GLYCERINPDC6A3C0OXIACT
GLYCYRRHIZA GLABRA (LICORICE) ROOT POWDER2788Z9758HIACT
ISOPROPYL ALCOHOLND2M416302IACT
TEA TREE OILVIF565UC2GIACT
THYMECW657OBU4NIACT
WATER059QF0KO0RIACT
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
FUNGLARA Anti FungalUNDECYLENIC ACIDFUNGLARA LLCa23c2399-36ea-4f22-8140-066e22c9a8622025-08-20WarningsExact identifier
ndc (package): 87028-876-00
ndc (product): 87028-876
ndc11 (package): 87028087600
spl id: 3ccad023-1b55-ffa3-e063-6294a90a28fb
spl set id: a23c2399-36ea-4f22-8140-066e22c9a862

Reported adverse events (FAERS/openFDA)#

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