Active ingredient

Undecylenic Acid 25%

Purpose

Antifungal

Uses

For the treatment of: most Athlete's Foot (Tinea Pedis), Ringworm (Tinea Corporis). For relief of: itching, scaling, cracking, burning, redness, soreness, irritation and discomfort which may accompany these conditions.

Warnings

For external use only

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

Extremely flammable
Keep away from fire or flame
Avoid smoking during use and until product has dried

Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away

Discontinue use and consult a doctor if irritation occurs or there is no improvement within 4 weeks

Directions

Read all directions and warnings before use
Clean affected area with soap and warm water and dry thoroughly
Apply a thin layer of Flexitol Anti-Fungal Liquid over the affected area twice daily (morning and night) or as directed by a doctor
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. If condition persists longer, consult a doctor.
Persons under 18 years of age or those with sensitive skin should use only as directed by a doctor
Supervise children in the use of this product
This product is not effective on the scalp or nails
Replace cap and tighten after each use

Other information

Store between 50° – 86°F in a dry place

Inactive ingredients

Isopropyl Alcohol, Water, Urea, Eucalyptus Globulus Leaf Oil, Hydroxypropyl Methylcellulose, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tocopherol Acetate, Aloe Barbadensis Leaf Juice, BHT

Comments or questions?

Call Toll Free 1-866-478-3338
usainfo@flexitol.com
www.flexitol.com

PRINCIPAL DISPLAY PANEL - 30ml Carton

Flexitol®

Anti-Fungal
Liquid

Treats Fungus

APPROVED
AMERICAN
PODIATRIC
MEDICAL
ASSOCIATION

Clinically Proven

Easy brush-on APPLICATOR

WITH UREA, ALOE VERA, VITAMIN E,
TEA TREE & EUCALYPTUS OILS

1 fl oz (30ml)

FLEXITOL ANTI FUNGAL
undecylenic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	43251-3351
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Undecylenic acid (Undecylenic acid)	Undecylenic acid	250 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Isopropyl Alcohol
Water
Urea
Eucalyptus Oil
Hypromellose 2906 (4000 MPA.S)
Tea Tree Oil
.Alpha.-Tocopherol Acetate, DL-
Aloe Vera Leaf
Butylated Hydroxytoluene

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	43251-3351-1	1 BOTTLE In 1 CARTON	contains a BOTTLE
1		30 mL In 1 BOTTLE	This package is contained within the CARTON (43251-3351-1)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333C	01/03/2009

Labeler - Laderma Trading Pty Ltd (758651624)

Revised: 04/2011Laderma Trading Pty Ltd