FungiNail Toe and Foot Anti-Fungal Solution

Manufacturer
Denison Pharmaceuticals, LLC.
Effective date
2019-02-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:31:41

Label at a glance#

ProductFungi Nail Toe and Foot Anti-Fungal
Active ingredientUNDECYLENIC ACID
Label structure11 sections

Storage and handling

Other information Store at room temperature 15°-30° C (59°-86° F). Protect from freezing. If freezing occurs warm to room temperature.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient....................Purpose

Undecylenic Acid.....................Anti-fungal

INDICATIONS & USAGE SECTION

Uses ■ Proven effective in the treatment of most athlete’s foot (tinea pedis) and ringworm (tinea corporis). ■ For effective relief of itching, burning and cracking.

Warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

When using this product ■ avoid contact with eyes.

OTC - STOP USE SECTION

Stop use and ask a doctor if ■ Irritation occurs. ■ There is no improvement within 4 weeks.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.
In case of accidental ingestion, contact a physician, emergency medical care facility or Poison Control Center immediately for advice.

DOSAGE & ADMINISTRATION SECTION

Directions ■ Clean affected areas with soap and warm water and dry thoroughly. ■ Apply a thin layer of Fungi-Nail ® Toe & Foot ® Anti-fungal Solution over affected area twice daily (morning and night) or as directed by a doctor. ■ The brush applicator allows for easy application under nails and surrounding cuticle area. ■ 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. ■ This product is not effective on the scalp or nails. ■ Supervise children in the use of this product.

STORAGE AND HANDLING SECTION

Other information Store at room temperature 15°-30° C (59°-86° F). Protect from freezing. If freezing occurs warm to room temperature.

INACTIVE INGREDIENT SECTION

Inactive ingredient

Isopropyl Palmitate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Products#

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DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0295-90320295-9032-05, 0295-9032-16, 0295-9032-11

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
8140da3a-a17a-0299-e053-2a91aa0a14548140da3a-a179-0299-e053-2a91aa0a14542019-02-06WarningsExact identifier
spl id: 8140da3a-a17a-0299-e053-2a91aa0a1454
spl set id: 8140da3a-a179-0299-e053-2a91aa0a1454

Reported adverse events (FAERS/openFDA)#

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