UNDECYLENIC ACID- antifungal solution liquid

Undecylenic Acid by

Drug Labeling and Warnings

Undecylenic Acid by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Undecylenic acid 25%w/w

Purpose

Antifungal

Uses

For cure of most tinea pedis (athete's foot) and tinea corporis (ringworm)

For relief of:

• discomforts which may accompany these conditons
• itching
• burning
• redness
• irritation
• scaling
• soreness

Warnings

For external use only.

If pregnant or breastfeeding

consult a healthcare professional before use.

Do not use

on children under 2 years of age unless directed by the doctor.

When using this product

avoid contact with eyes.

use only as directed

by the doctor on persons with highly sensitive skin.

Stop use and consult a doctor if

• there is no improvement within 4 weeks
• irritation occurs

Keep out of reach of children.

If accidental ingestion occurs, get medical help or contact a Poison Control Center right away.

Directions

Read all warnings and directions. Use only as directed.

• clean the affected area and dry thoroughly
• apply a thin layer of the product over the affected area twice daily (morning and evening) or as directed by a doctor
• supervise children in the use of this product
• for athlete's foot: pay special attention to spaces between the toes
• wear well- fitting, ventilated shoes, and changes shoes and socks atleast once daily
• for athlete's foot and ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.
• this product is not effective on the scalp or nails

other information

• store at room temperature 150 - 300C (590 - 860F)
• protect from freezing. If freezing occurs warm to room temperature
• keep tightly closed when not in use

Inactive ingredient

isopropyl palmitate

Questions?

Call 1-888-423-0139

Principal Display Panel

Topcare health

Maximum strength

Anti- Fungal Liquid

Undecylenic Acid 25%

Eliminates fungus on fingers, toes, and around nails

• Easy to apply Application Brush 
• Dries quickly
• Non-oily,Clear Formula
• No Unpleasent Odor

1 FL OZ (30mL)

INGREDIENTS AND APPEARANCE

UNDECYLENIC ACID 
antifungal solution liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-372
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Undecylenic Acid (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	Undecylenic Acid	7.5 g  in 30 g

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-372-30	30 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	12/12/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	12/12/2017

Labeler - Topco Associates LLC (006935977)