Label: FLEXITOL ANTI FUNGAL- undecylenic acid liquid

  • 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 December 20, 2012

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  • 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)

    PRINCIPAL DISPLAY PANEL - 30ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    FLEXITOL ANTI FUNGAL 
    undecylenic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43251-3351
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Undecylenic acid (UNII: K3D86KJ24N) (Undecylenic acid - UNII:K3D86KJ24N) Undecylenic acid250 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 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)
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