FLEXITOL ANTI FUNGAL- undecylenic acid liquid

Flexitol Anti Fungal by

Drug Labeling and Warnings

Flexitol Anti Fungal by is a Otc medication manufactured, distributed, or labeled by LaCorium Health International Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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

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

Comments or questions?

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

PRINCIPAL DISPLAY PANEL - 30ml Bottle 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

NDC: 43251-3351

1 fl oz (30ml)

INGREDIENTS AND APPEARANCE

FLEXITOL ANTI FUNGAL 
undecylenic acid liquid

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Undecylenic acid (UNII: K3D86KJ24N) (Undecylenic acid - UNII:K3D86KJ24N)	Undecylenic acid	250 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Isopropyl Alcohol (UNII: ND2M416302)
Water (UNII: 059QF0KO0R)
Urea (UNII: 8W8T17847W)
Eucalyptus Oil (UNII: 2R04ONI662)
Hypromellose 2906 (4000 MPA.S) (UNII: 5EYA69XGAT)
Tea Tree Oil (UNII: VIF565UC2G)
.Alpha.-Tocopherol Acetate, DL- (UNII: WR1WPI7EW8)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43251-3351-1	1 in 1 CARTON
1		30 mL in 1 BOTTLE

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

Labeler - LaCorium Health International Pty Ltd (758651624)