Topical Anti-Fungal Solution by Wintermute Biomedical, Inc. / Wintermute Biomedical, Inc / Mayne Pharma International Pty Ltd Drug Facts

Topical Anti-Fungal Solution by

Drug Labeling and Warnings

Topical Anti-Fungal Solution by is a Otc medication manufactured, distributed, or labeled by Wintermute Biomedical, Inc., Wintermute Biomedical, Inc, Mayne Pharma International Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TOPICAL ANTI-FUNGAL SOLUTION- undecylenic acid liquid 
Wintermute Biomedical, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredient

Undecylenic Acid 15%

Purpose

Antifungal

Uses

Proven effective in the treatment of:

* Athlete's foot

* Jock itch

* Ringworm

Relieves:

* Itchine

*Scaling
* Burning

* Redness

* Irritation

* Discomfort

Warnings

* 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

* On children under 2 years of age unless directed by a doctor

When using this product

*Avoid contact with the eyes

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

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

Directions

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

L-arginine, Purified Water

Questions?

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

Prinicipal 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 SOLUTION 
undecylenic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80103-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	15 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ARGININE (UNII: 94ZLA3W45F)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80103-001-20	20 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/30/2020	08/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M005	08/30/2020	08/30/2020

Labeler - Wintermute Biomedical, Inc. (078573246)

Registrant - Wintermute Biomedical, Inc. (078573246)

Establishment
Name	Address	ID/FEI	Business Operations
Wintermute Biomedical, Inc.		078573246	pack(80103-001) , label(80103-001)

Establishment
Name	Address	ID/FEI	Business Operations
Mayne Pharma International Pty Ltd		756003745	manufacture(80103-001)

Revised: 1/2023

Document Id: f05ea9c7-81c7-4398-e053-2a95a90a10d8

34390-5

Set id: ae1f9e9d-ab8d-b526-e053-2995a90a2dc9

Version: 2

Effective Time: 20230102