Topical Anti-Fungal Solution

Manufacturer
Wintermute Biomedical, Inc. | Wintermute Biomedical, Inc | Mayne Pharma International Pty Ltd
Effective date
2020-08-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:16:43

Label at a glance#

ProductTopical Anti-Fungal Solution
Active ingredientUNDECYLENIC ACID
Label structure8 sections

Indications and uses

Proven effective in the treatment of: * Athlete's foot * Jock itch * Ringworm Relieves: * Itchine *Scaling * Burning * Redness * Irritation * Discomfort

Dosage and administration

Directions of Use: * Clean the affected area and dry thoroughly * Apply a thin layer or the product over affected area twise daily or as directed by a doctor. * Supervise children in the use of this product * For athlete's foot: Pay special attention to the 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 ...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid 15%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

Proven effective in the treatment of:

* Athlete's foot

* Jock itch

* Ringworm

Relieves:

* Itchine

*Scaling
* Burning

* Redness

* Irritation

* Discomfort

Warnings

WARNINGS SECTION

* For external use only

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

* Avoid contact with the eyes

* If swallowed seek medical attention

* Keep out of reach of children

* If accidental ingestion occurs, rinse mouth with water and contact a Poison Control Center right away

* For the treatment of athlete's foot and ringworm; if irritation offurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.

* For the treatment of jock itch: if irritation occurs of it there is no improvement within 2 weeks, discontinue use and consult a doctor.

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

Ask doctor section

OTC - ASK DOCTOR SECTION

* For treatment of athlete's foot and ringworm; if irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.

* For the treatment of jock itch: if irritation occurs or it there is no improvement within 2 weeks, discontinue use and consult a doctor.

Keep out

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If accidental ingestion occurs, rinse mouth with water and contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions of Use:

* Clean the affected area and dry thoroughly

* Apply a thin layer or the product over affected area twise daily or as directed by a doctor.

* Supervise children in the use of this product

* For athlete's foot: Pay special attention to the 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

* For Jock itch: use daily for 2 weeks. If conditions persists longer, consult a doctor.

* This product is not effective on the scalp or nails.

Inactive ingredients

INACTIVE INGREDIENT SECTION

L-arginine, Purified Water

Questions?

OTC - QUESTIONS SECTION

For additional informaiton, please call +1-888-568-7306

Prinicipal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Wintermute Biomedical

Topical Anti-Fungal Solution

For skin conditions

Contains Undecylenic acid 15%W/W

Store at room temperature

Wintermute Biomedical Inc.

4 Research Ave

Bundroora VIC 3083

Australia

+1-888-568-7306

Made in Australia

NDC 80103-001-xx

Topical Anti-Fungal Sol_20mLTopical Anti-Fungal Sol_20mL

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80103-00180103-001-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
UNDECYLENIC ACIDK3D86KJ24NACTIB
ARGININE94ZLA3W45FIACT
WATER059QF0KO0RIACT

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
f05ea9c7-81c7-4398-e053-2a95a90a10d8ae1f9e9d-ab8d-b526-e053-2995a90a2dc92023-01-02WarningsExact identifier
spl set id: ae1f9e9d-ab8d-b526-e053-2995a90a2dc9

Reported adverse events (FAERS/openFDA)#

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