Fungicure

Alva-Amco Pharmacal Companies, Inc.

Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient
• Purpose
• Fungicure Uses
• Warnings
• Stop use and ask a doctor if
• Directions
• Fungicure Other information
• Inactive ingredient

FULL PRESCRIBING INFORMATION

Active ingredient

Clotrimazole, 1% w/v

Purpose

Antifungal

Fungicure 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.

Warnings

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
• 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 use.
• Use only as directed.
• Clean the affected area with soap and warm water and dry thoroughly.
• Apply a thin layer of Fungicure Manicure & Pedicure Liquid 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 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.

Fungicure 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 intact 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.
  

Inactive ingredient

Isopropyl alcohol

Questions? 1-800-792-2582

Maximum Strength

FUNGICURE Manicure & Pedicure

Anti-Fungal Treatment

• Easy Brush-On
• Instant Dry
• Odor Free
• Crystal Clear

The Manicure & Pedicure Fungi Specialist

A WORD ABOUT FUNGICURE Manicure & Pedicure Formula:

With your purchase of FUNGICURE Manicure & Pedicure Formula, you have chosen a highly effective and remarkably convenient treatment for common fungus infection of the finger and toe areas, including on cuticles and skin around and adjacent to nails edges and under nail tips where reachable with its convenient applicator brush.

Maintaining the appearance of your manicure and pedicure requires more than cosmetics. Proper hygiene is essential to help avoid potentially painful and unsightly fungus infections. FUNGICURE Manicure & Pedicure Formula is a maximum strength anti-fungal liquid, specifically formulated for the special needs of those who manicure, pedicure or use artificial nails-including manicure and nail care professionals.

FUNGICURE Manicure & Pedicure Formula is highly effective against common skin and cuticle area fungal infections, which can migrate to the nails. FUNGICURE Manicure & Pedicure Formula's convenient applicator brush allows for controlled, easily targeted application of anti-fungal medicine directly and neatly to the site of infection. FUNGICURE Manicure & Pedicure Formula dries fast and thoroughly, avoiding the mess and excess spreading so often associated with creams and "drop-on" liquids. With FUNGICURE, fingers need never touch infected areas. FUNGICURE Manicure & Pedicure Formula is crystal clear and leaves no 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 surface through even the smallest crack or tear. They may be contracted by touching infected surfaces, animals or other people. Once infection starts, spreading may occur among body parts...one finger to another...one toe to another...from the skin and cuticle areas to the nails. There are a number of specific types of fungi, each of which can potentially infect 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 in between the fingers and toes including the skin around the nails. Other common fungi are 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 like FUNGICURE.

Fungal infections of the finger and toe areas present a special risk for those who manicure, pedicure or wear artificial nails. Many manicure procedures can enhance the risk of fungal infection. Certain types of artificial nails can trap moisture and fungi, providing a perfect environment in which fungus can grow and spread. Cutting cuticles can create opportunities for fungal infections. Treating fungal infections on cuticles and nearby skin surfaces helps greatly reduce the risk of it spreading and attacking healthy nails. Stopping fungus before it infects healthy nails is the number one strategy for dealing with this potentially unsightly and very troublesome problem.

FUNGICURE Manicure & Pedicure Formula is a highly effective treatment, which helps eliminate fungus on cuticles and skin around and adjacent to the nails. Rely on FUNGICURE Manicure & Pedicure Formula liquid as an important anti-fungal defense.

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

Some topical infections may present themselves on the skin as ringlike 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.

HOW FUNGICURE MANICURE & PEDICURE FORMULA LIQUID WORKS; PRODUCT DESCRIPTION AND ACTION:

FUNGICURE Manicure & Pedicure Formula is an effective topical formulation containing the ACTIVE INGREDIENT: Clotrimazole (1% w/v) INACTIVE INGREDIENT: Isopropyl alcohol.

The active ingredient Clotrimazole in FUNGICURE Manicure & Pedicure Formula is a widely recognized proven anti-fungal ingredient effective against fungi such as E. floccosum, T. mentagrophytes, 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 Manicure & Pedicure Formula acts promptly to eliminate fungus at the site of infection while preventing its spread...plus helps relieve associated burning, itching and discomforts...allowing for the regrowth of healthy looking skin.

WHY FUNGICURE MANICURE & PEDICURE LIQUID 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 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 is breached and the nail bed, harboring fungus, is exposed, FUNGICURE Manicure & Pedicure Anti-Fungal Liquid, 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 Manicure & Pedicure Anti-Fungal Liquid 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 may require consultation from a Doctor or Pharmacist for proper treatment. You may wish to show them FUNGICURE Manicure & Pedicure Anti-Fungal Liquid 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 Manicure & Pedicure Formula, it is continued uninterrupted, carefully following package directions, until satisfactory results are achieved or further 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 FUNGUS INFECTIONS AND REINFECTIONS:

• 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.
• In cases where athlete's foot (tinea pedis) has been a problem, wear well ventilated shoes and change to clean socks at least once daily.
• All manicure and pedicure implements should be kept meticulously clean and sterilized after each use.
• Women who use artificial nails regularly should watch for changes in their nails. If nails become brittle, cracked or discolored it may be appropriate to avoid artificial nails for a period of time and a good idea to consult your doctor for advice.
• Avoid any practices that can tear or bruise the skin. Avoid trimming back cuticles too far, and cutting nails too close. Anything that tears or opens the skin invites infections. Be very observant for early signs of reinfections and don't hesitate to take prompt action with FUNGICURE Manicure & Pedicure Formula.

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. Inhibits the growth and reproduction of fungal cells.

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 • 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 use. • Use only as directed. • Clean the affected area with soap and warm water and dry thoroughly. • Apply a thin layer of FUNGICURE Manicure & Pedicure Liquid 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. 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 the 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 intact nail surfaces. • While not all finger and toe area 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: As a topical liquid: net contents 1 fl. oz. (30 ml) in a bottle with brush applicator. Storage: Keep tightly closed when not in use. Store away from excessive heat and cold.

When it comes to your manicure and pedicure, rely on FUNGICURE Manicure & Pedicure Formula Anti-Fungal Liquid - The Manicure & Pedicure Fungi Specialist - to help eliminate and prevent the spread of fungal infections of the finger and toe areas.