Label: FUNGICURE MAXIMUM STRENGTH- undecylenic acid gel 

  • Label RSS
  • NDC Code(s): 52389-633-09
  • Packager: Alva-Amco Pharmacal Companies, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/12

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Undecylenic acid 25% w/w

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  • Purpose

    Antifungal

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  • Uses

    For the cure of most

    • ringworm (tinea corporis)
    • athlete's foot (tinea pedis)

    For relief of

    • itching
    • scaling
    • cracking
    • burning
    • redness
    • soreness
    • irritation
    • discomforts which may accompany these conditions.
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  • Warnings

    For external use only



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  • ASK DOCTOR

    Ask a doctor before use on children under 2 years of age.

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  • WHEN USING

    When using this product avoid contact with the eyes.

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  • Stop use and ask a doctor if


    • Irritation occurs
    • There is no improvement within 4 weeks.
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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed, get medical help or contact a poison control center right away.

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  • Directions

    • Read all package directions and warnings before using.
    • Use only as directed.
    • Clean the affected area with soap and warm water and dry thoroughly.
    • Apply a thin layer of Fungicure over the affected area twice daily (morning and night), or as directed by a doctor.
    • This product is not effective on scalp or nails.
    • For athlete's foot, pay special attention to spaces between 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.
    • Intended for use by normally healthy adults only.
    • Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor.
    • Supervise children in the use of this product.
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  • Other information

    • Fungicure may be applied to cuticles, around nail edges and under nail tips where reachable with its applicator brush.
    • This product is not intended to, nor will it, penetrate hard nail surfaces.
    • While not all finger and toe fungal infections are curable with OTC topical medications, if you see improvement within 4 weeks of use, you may continue to use Fungicure until satisfactory results are obtained.
    • You may report serious side effects to the phone number provided under Questions? below.
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  • Inactive ingredients

    Aloe vera gel, hydroxypropylcellulose, isopropyl alcohol (70% v/v), purified water and vitamin E.

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  • QUESTIONS

    Questions? 1-800-792-2582

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  • Fungicure Maximum Strength Liquid Gel Insert

    Maximum Strength FUNGICURE Liquid Gel

    Anti-Fungal Treatment

    BROAD SPECTRUM

    Kills 6 types of fungus on fingers and toes including around, adjacent to, and under nails where reachable with its QuickBrush applicator

    Advanced Liquid Gel Technology

    Inhibits the Growth and Reproduction of Fungal Cells

    Stops fungus

    • Easy Brush-on Liquid Gel Locks onto Site of Infection
    • No Medicinal Odor
    • Crystal Clear, Dries Fast with No Mess
    • Contains Aloe and Vitamin E

    A WORD ABOUT MAXIMUM STRENGTH FUNGICURE ANTI-FUNGAL LIQUID GEL:

    Fungicure Liquid Gel provides a sturdy, no mess dispensing brush tip that gets the active ingredient into the precise areas where it can effectively fight infection. The innovative liquid gel base is formulated to adhere to infected surfaces wherever reachable with the Fungicure Precision QuickBrush applicator. FUNGICURE's Precision QuickBrush applicator allows for controlled, targeted application so medicine may be applied directly and neatly to the site of infection. With FUNGICURE Liquid Gel your fingers need never touch affected areas. FUNGICURE Liquid Gel dries fast without messy residue or unpleasant medicinal odor.

    WHAT IS FUNGUS INFECTION OF THE FINGER AND TOE AREAS?

    Generally speaking, common fungus infections of the finger and toe areas (topical infections) are caused by a variety of fungi; actual living organisms (members of the yeast and mold family) which exist in the natural environment and tend to thrive in dark, damp conditions. These organisms may penetrate the skin's surface through even the smallest crack or tear and may be contracted by touching infected surfaces, animals or people. Once infection starts, spreading may occur among body parts...one toe to another...one finger to another. There are a number of specific types of fungi, each of which can affect body tissue and proceed to grow. Common topical fungi infectives generally fall into three categories: microsporum (hair and skin), epidermophyton (skin and nails), and trichophyton (hair, skin and nails). Among the more common fungi is E. floccosum which can cause ringworm infection on the body, hands and feet, on and between fingers and toes, including the skin around the nails. Other common fungi are M. canis, which can cause ringworm affecting the body and hands; M. gypseum, which can cause ringworm on the trunk of the body and the skin around the nails; T. tonsurans, which can cause ringworm and athlete's foot, including infecting the skin around the nails; and T. rubrum and T. mentagrophytes which can cause athlete's foot and infect the feet, on and between the toes including the skin around the toenails. Often such infections develop slowly and may be difficult to treat if not attended to promptly with an effective anti-fungal medicine like FUNGICURE.

    HOW DO YOU KNOW IF YOU HAVE A TOPICAL FUNGUS INFECTION?

    Some topical fungal infections may present themselves on the skin as ring-like formations with clear centers, commonly referred to as ringworm. Other such infections, when in the finger and toe areas, are often characterized by scaling of skin, burning, cracking, itching and related discomforts. When nails become infected, they may appear to become opaque (cloudy white), thickened, brittle, friable (easily broken) and in some cases, discolored (greenish/brown). NOTE: If you believe you may have any type of fungus infection, do not delay consulting a doctor for advice. You may wish to show him/her FUNGICURE Liquid Gel and discuss its use.

    HOW FUNGICURE LIQUID GEL WORKS; PRODUCT DESCRIPTION AND ACTION:

    MAXIMUM STRENGTH FUNGICURE Liquid Gel is an effective topical formulation containing the ACTIVE INGREDIENT: Undecylenic Acid 25% w/w INACTIVE INGREDIENTS: Aloe vera gel, hydroxypropylcellulose, isopropyl alcohol (70% v/v), purified water, vitamin E.

    Undecylenic acid in FUNGICURE Liquid Gel is a widely recognized, proven anti-fungal ingredient effective against 6 types of fungus including E. floccosum, T. mentagrophytes, M. canis, M gypseum, T. tonsurans and T. rubrum, which are known to cause topical infections of the body, hands and feet, including on and between fingers and toes, as well as on cuticles and skin around nails.

    FUNGICURE Liquid Gel acts promptly to target and destroy fungus at the site of infection while preventing its spread. FUNGICURE helps relieve associated burning, itching and discomforts by eliminating the fungus...allowing for the natural regrowth of healthy looking tissue.

    WHY FUNGICURE LIQUID GEL IS SO EFFECTIVE IN NAIL AREA INFECTION:

    Fungal infection of the nail areas can affect both the nail beds as well as the nail surfaces themselves, commonly referred to as the nail plates. While an actual intact nail plate, being a hard surface, is generally not readily penetrable by topical applications, there are instances where nail plates are not intact and are actually cracked open, breached or otherwise exposed, either partially or fully, including instances where a nail plate has actually lifted away and separated from its nail bed. There are other instances where fungus resides on skin around and adjacent to the nail plate, at the very edges, on the cuticles, and under the exposed quick of the nail. In these instances where the nail itself and the nail bed, harboring fungus, are exposed, FUNGICURE Anti-Fungal Liquid Gel, with its powerful anti-fungal action, applied as directed, is able to reach the fungus by direct application or by related capillary action. Reaching the actual site where the fungus resides, FUNGICURE Anti-Fungal Liquid Gel eliminates the fungus, and in so doing, allows for the re-growth of healthy nail bed and nail plate tissue.

    Fungal infections which are isolated beneath an intact nail plate or embedded within the nail plate itself may require consultation from a Doctor or Pharmacist for proper treatment. You may wish to show them FUNGICURE Liquid Gel and discuss its use.

    PROMPT ACTION AND PROPER TREATMENT:

    Recognizing and treating fungus infection early is very important for successful results. Therefore, it is wise to consult your doctor promptly for advice if you suspect you may have a fungal Infection. It is likewise important, for successful results, that once treatment is started with FUNGICURE it is continued uninterrupted, carefully following package directions, until satisfactory results are achieved or advised by a doctor, as directed on the package.

    NOTE: Noticeable improvement may be expected within 4 weeks in the case of ringworm (tinea corporis) and athlete's foot (tinea pedis). Consult your doctor for advice if noticeable improvement is not evident by this time or if condition persists or worsens.

    HOW TO AVOID RECURRENCE OF FUNGUS INFECTION?

    1. Since fungus enjoys and thrives on moisture, keep hands and feet meticulously clean and dry. Good personal hygiene is your first line of defense against recurring fungus infections.
    2. In cases where athlete's foot (tinea pedis) has been a problem, wear well ventilated shoes and wear clean socks daily.
    3. Avoid any practices that can tear or bruise the skin. Avoid trimming cuticles back too far and avoid cutting nails too close. Anything that tears or opens the skin invites fungus to invade.

    Uses: For the cure of most:  ringworm (tinea corporis) and athlete's foot (tinea pedis). For relief of:  itching, scaling, cracking, burning, redness, soreness, irritation and discomforts which may accompany these conditions.

    Warnings:

    For external use only.

    Ask a doctor before use on children under 2 years of age.

    When using this product avoid contact with the eyes.

    Stop use and ask a doctor if irritation occurs or there is no improvement within 4 weeks.

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

    Directions:  Read all package directions and warnings before using.  Use only as directed.  Clean the affected area with soap and warm water and dry thoroughly.  Apply a thin layer of FUNGICURE Liquid Gel over the affected area twice daily (morning and night), or as directed by a doctor.  This product is not effective on scalp or nails.  For athlete's foot, pay special attention to spaces between 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.  Intended for use by normally healthy adults only.  Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor.  Supervise children in the use of this product.

    Other Information: FUNGICURE may be applied to cuticles, around nail edges and under nail tips where reachable with its applicator brush. This product is not intended to, nor will it, penetrate hard nail surfaces. While not all finger and toe fungal infection are curable with OTC topical medications, if you see improvement within 4 weeks of use, you may continue to use FUNGICURE until satisfactory results are obtained.  You may report serious side effects to the phone number provided under Questions? below.

    Inactive ingredients Aloe vera gel, hydroxypropylcellulose, isopropyl alcohol (70% v/v), purified water and vitamin E.

    Questions? 1-800-792-2582

    fungicure.com

    The active ingredient in Fungicure has been recognized to be safe and effective by an FDA Expert Advisory Panel when used as directed.

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  • INGREDIENTS AND APPEARANCE
    FUNGICURE  MAXIMUM STRENGTH
    undecylenic acid gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52389-633
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Undecylenic acid (Undecylenic acid) Undecylenic acid 250 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Aloe vera leaf  
    HYDROXYPROPYL CELLULOSE  
    Isopropyl alcohol  
    Water  
    .ALPHA.-TOCOPHEROL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52389-633-09 1 in 1 BOX
    1 9 g in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 11/30/2012
    Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)
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