FLEXITOL MEDICATED FOOT- tolnaftate cream 
LaCorium Health International Pty Ltd

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.

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Flexitol Medicated Foot Cream

Drug Facts

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

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

Other Information

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)

PRINCIPAL DISPLAY PANEL - 56 g Tube Carton
FLEXITOL MEDICATED FOOT 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43251-3340
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Tolnaftate (UNII: 06KB629TKV) (Tolnaftate - UNII:06KB629TKV) Tolnaftate1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Urea (UNII: 8W8T17847W)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Mineral Oil (UNII: T5L8T28FGP)  
Glycerin (UNII: PDC6A3C0OX)  
Propylene glycol (UNII: 6DC9Q167V3)  
Petrolatum (UNII: 4T6H12BN9U)  
Polysorbate 60 (UNII: CAL22UVI4M)  
Ceteth-20 (UNII: I835H2IHHX)  
Cetyl alcohol (UNII: 936JST6JCN)  
Menthol (UNII: L7T10EIP3A)  
Sodium phosphate (UNII: SE337SVY37)  
Benzalkonium chloride (UNII: F5UM2KM3W7)  
Tocopherol (UNII: R0ZB2556P8)  
Lavender Oil (UNII: ZBP1YXW0H8)  
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43251-3340-11 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/FEIBusiness Operations
Jalco Pharmaceuticals Pty Ltd757701409MANUFACTURE(43251-3340) , PACK(43251-3340) , LABEL(43251-3340) , ANALYSIS(43251-3340)

Revised: 11/2012
Document Id: 32d36fb9-913b-4581-a2af-dc45211a4a4b
Set id: c31da255-e671-41e3-8607-efbb6973163c
Version: 1
Effective Time: 20121112
 
LaCorium Health International Pty Ltd