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Flexitol Medicated Foot

Dosage form: cream
Ingredients: Tolnaftate 1g in 100g
Labeler: LaCorium Health International Pty Ltd
NDC Code: 43251-3340

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.

Flexitol Medicated Foot Cream

Drug Facts

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses
  • Clinically proven to prevent Athlete's Foot (Tinea Pedis) and Ringworm (Tinea Corporis) with daily use
  • For effective relief of symptoms of Athlete's Foot, including itching, burning, cracking, scaling and discomfort associated with this condition.

Warnings

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

  • For External Use Only
  • Avoid contact with eyes

  • If irritation occurs or if there is no improvement within 4 weeks (for Athlete's Foot) discontinue use and consult a doctor

  • Do not use if seal on tube is punctured or is not visible. Keep out of reach of children.

Directions
  • Clean the affected area and dry thoroughly
  • Apply a thin layer of the product over the affected area twice daily (morning and night), 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.
  • Use daily for 4 weeks. If condition persists longer consult a doctor.
  • To prevent Athlete's Foot, apply once or twice daily (morning and/or night)
  • 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, Benzalkonium Chloride, Cetearyl Alcohol, Ceteth-20, Cetyl Alcohol, Glycerin, Lavandula, Angustifolia (Lavender) Oil, Menthol, Mineral Oil, Petrolatum, Polysorbate 60, Propylene Glycol, Sodium Phosphate, Tocopherol, Urea, Water

Questions or comments?

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

USA DISTRIBUTOR:
LaCorium Health USA Inc.,

Boca Raton, Florida 33487

MANUFACTURED FOR:
LaCorium Health International Pty Ltd.,

Level 14, Tower 2,
101 Grafton Street,
Bondi Junction NSW 2022, Australia

PRINCIPAL DISPLAY PANEL - 56 g Tube Carton

Flexitol®

Medicated
Foot Cream

For treatment of
athlete's foot

Before

After 2 Weeks

APPROVED

AMERICAN
PODIATRIC
MEDICAL
ASSOCIATION

With Aloe & Vitamin E

DIABETIC FRIENDLY

Net Wt 2 oz (56 g)

FLEXITOL MEDICATED FOOT 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43251-3340
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Tolnaftate (Tolnaftate) Tolnaftate1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Urea 
Cetostearyl Alcohol 
Mineral Oil 
Glycerin 
Propylene glycol 
Petrolatum 
Polysorbate 60 
Ceteth-20 
Cetyl alcohol 
Menthol 
Sodium phosphate 
Benzalkonium chloride 
Tocopherol 
Lavender Oil 
Aloe Vera Leaf 
Water 
Packaging
#Item CodePackage Description
1NDC:43251-3340-11 TUBE in 1 CARTON
156 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C08/11/2012
Labeler - LaCorium Health International Pty Ltd (758651624)
Establishment
NameAddressID/FEIOperations
Jalco Pharmaceuticals Pty Ltd757701409MANUFACTURE(43251-3340), PACK(43251-3340), LABEL(43251-3340), ANALYSIS(43251-3340)

 
LaCorium Health International Pty Ltd

Medically reviewed on Nov 12, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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