Your browser does not support JavaScript! FLEXITOL ANTI FUNGAL (UNDECYLENIC ACID) LIQUID [LACORIUM HEALTH INTERNATIONAL PTY LTD]
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FLEXITOL ANTI FUNGAL (undecylenic acid) liquid
[LaCorium Health International Pty Ltd]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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)

PRINCIPAL DISPLAY PANEL - 30ml Bottle Carton
FLEXITOL ANTI FUNGAL 
undecylenic acid liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:43251-3351
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Undecylenic acid (Undecylenic acid) Undecylenic acid250 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Isopropyl Alcohol 
Water 
Urea 
Eucalyptus Oil 
Hypromellose 2906 (4000 MPA.S) 
Tea Tree Oil 
.Alpha.-Tocopherol Acetate, DL- 
Aloe Vera Leaf 
Butylated Hydroxytoluene 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43251-3351-11 in 1 CARTON
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C01/03/2009
Labeler - LaCorium Health International Pty Ltd (758651624)

Revised: 12/2012
 
LaCorium Health International Pty Ltd

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