Label: FUNGICURE INTENSIVE- clotrimazole liquid

  • NDC Code(s): 52389-600-60
  • Packager: Alva-Amco Pharmacal Companies, Inc.
  • 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 July 11, 2017

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  • Active ingredient

    Clotrimazole 1% w/v

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  • Purpose

    Antifungal

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  • Uses

    For the cure of most:

    • athlete's foot (tinea pedis)
    • ringworm (tinea corporis)
    • jock itch (tinea cruris)

    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 (2 weeks for jock itch)


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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.
    • Spray 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 the scalp or nails.
    • Avoid applying to severely cracked or irritated areas.
    • 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; for jock itch, use daily for 2 weeks.
    • Supervise children in the use of this product.
    • 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.
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  • Other information

    Spray FUNGICURE INTENSIVE on cuticles, around nail edges and under nail tips. While not all finger and toe 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 ingredient

    Isopropyl alcohol

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  • QUESTIONS

    Questions?  1-800-792-2582

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  • Package Insert

    FUNGICURE INTENSIVE

    Cures Finger and Toe Area Fungal Infections

    Broad Spectrum - Kills 6 types of fungus on exposed nail beds

    WHAT IS FUNGUS INFECTION OF THE FINGER AND TOES?

    Common topical fungus infections of the fingers and toes are caused by a variety of fungi; actual living organisms (members of the yeast and mold family) which thrive in dark, moist conditions. Using small breaches in the skin's surface, these organisms can cause infection by contact with infected surfaces, animals or people. Once infection starts, spreading may occur. For example, infected fingers and toes may infect other fingers and toes. Although such infections often develop slowly, they may be difficult to eliminate if not treated 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 surface as ring-like formations with clear centers; this is commonly called ringworm.  Athlete's foot fungus and jock itch fungus, 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, easily broken, and in some cases, discolored (greenish/brown).

    UNDERSTANDING AND TREATING A NAIL AREA INFECTION:

    Fungal infections of the nail areas are often caused by the same fungi that lead to athlete's foot, jock itch, and ringworm infections elsewhere on the body. These fungi can infect the entire area around the nails including the cuticles, the nail beds, and even the nails themselves. When infected finger/toe nails are intact, over-the-counter topical anti-fungal treatments may not be able to penetrate the nail and kill the fungus; this is why all OTC topical treatments must indicate they are not effective on the nails. However, in instances of advanced infection, the nails often are not not intact; they may be missing, cracked open or lifted away, exposing the infected nail bed. In these instances FUNGICURE Intensive, with its powerful anti-fungal formula, can reach and kill nail bed fungus by direct application or related capillary action. Fungicure cures the infection, allowing the natural regrowth of healthy looking tissue.

    NOTE: Fungal infections which are isolated beneath an intact nail or embedded within the nail itself may require consultation from a doctor for proper treatment.

    HOW FUNGICURE INTENSIVE WORKS:

    MAXIMUM STRENGTH FUNGICURE Intensive contains Clotrimazole, a widely recognized anti-fungal ingredient that has been proven to be effective aginst 6 types of fungus such as E. floccosum, T. mentagrophytes, M. canis, M. gypseum, T. tonsurans and T. rubrum.

    When applied as directed, FUNGICURE Intensive acts promptly to target, destroy, and prevent the spread of infection by inhibiting the growth and reproduction of fungal cells.

    PROMPT ACTION AND PROPER TREATMENT:

    Early treatment of fungal infections is important. If you suspect that you may have a fungal infection, consult your doctor promptly for advice and proper diagnosis. You may wish to show him/her FUNGICURE Itensive and discuss its use. For best results, once treatment is started with FUNGICURE Intensive, it is important to carefully follow the treatment instructions on the package until satisfactory results are achieved or advised further by a doctor.

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

    Active ingredient: Clotrimazole 1% w/v

    Uses: For the cure of most: athlete's foot (tinea pedis), ringworm (tinea corporis), jock itch (tinea cruris). 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 (2 weeks for jock itch).

    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 use. Use only as directed. Clean the affected area with soap and warm water and dry thoroughly. Spray a thin layer of FUNGICURE over the affected area (including the exposed nail bed) twice daily (morning and night), or as directed by a doctor. This product is not effective on the scalp or nails. Avoid applying to severely cracked or irritated areas. 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; for jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor. Supervise children in the use of this product. 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.

    Other Information: 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.

    Inactive ingredient: Isopropyl alcohol

    Questions? 1-800-792-2582

    How Supplied: 2 fl. oz. (60ml) non-aerosol pump spray.

    Storage: Keep container closed (capped) when not in use. Store away from excessive heat or cold.

    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  INTENSIVE
    clotrimazole liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52389-600
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Clotrimazole (UNII: G07GZ97H65) (Clotrimazole - UNII:G07GZ97H65) Clotrimazole 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Isopropyl alcohol (UNII: ND2M416302)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52389-600-60 1 in 1 BOX 06/05/2008
    1 60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 06/05/2008
    Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)
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