Label: FLEXITOL MEDICATED FOOT- tolnaftate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated November 12, 2012

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  • SPL UNCLASSIFIED SECTION

    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

  • SPL UNCLASSIFIED SECTION

    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
  • INGREDIENTS AND APPEARANCE
    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)
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