Fungicure

Alva-Amco Pharmacal Companies, Inc.

FULL PRESCRIBING INFORMATION: CONTENTS*

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

FULL PRESCRIBING INFORMATION

Active ingredient

Clotrimazole 1% w/v...................................Antifungal

Fungicure 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.

Stop use and ask a doctor if

• irritation occurs
• 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 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.
• 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.
• Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor.
• This product is not effective of the scalp or nails.

Fungicure Other information

Serious side effects associated with the use of this product may be reported to the phone number provided below.

Inactive ingredient

Isopropyl alcohol

Questions?  1-800-792-2582

Product Insert

FUNGICURE Anti-Fungal Liquid

Non Aerosol Pump Spray

Topical Formula

• Doctor Recommended
• Dries Instantly
• Crystal Clear and Odorless
• Cools, Soothes and Cures

A WORD ABOUT FUNGICURE PUMP SPRAY LIQUID:

FUNGICURE Anti-Fungal Pump Spray Liquid is strong medicine for the treatment of common fungus infections, specifically the cure of most athlete's foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris). FUNGICURE Pump Spray Liquid is crystal clear, odorless, and applies easily with its non-aerosol pump spray, delivering highly effective anti-fungal medication directly to the site of infection. With FUNGICURE Pump Spray, fingers need never touch affected areas.

WHAT IS FUNGUS INFECTION?

Generally speaking, common fungus infections are topical infections caused by a variety of fungi; actual living organisms (members of the yeast and mold family) which exist in varying degrees, at all times in nature, and tend to thrive in dark, damp and moist conditions...in the soil...on animals as well as humans. These organisms may penetrate the skin's surface through even the smallest crack or tear, may be spread from animals to humans and may be spread among humans. Once infection starts, spreading may occur from one site on the body to another. There are a number of specific types, each of which can potentially infect body tissue and proceed to grow unless treated appropriately with an effective anti-fungal medicine. 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 are E. floccosum which can cause ringworm infection and affects the body, hands and feet, on and in between the fingers including the skin around the fingernails; also 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.

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 Pump Spray Liquid and discuss its use.

HOW FUNGICURE PUMP SPRAY LIQUID ANTI-FUNGAL WORKS; PRODUCT DESCRIPTION AND ACTION:

FUNGICURE Pump Spray Liquid is an effective topical formulation containing the ACTIVE INGREDIENT: Clotrimazole 1% w/v. INACTIVE INGREDIENT: Isopropyl alcohol. The active ingredient Clotrimazole in FUNGICURE is a widely recognized, doctor recommended anti-fungal agent 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. FUNGICURE Pump Spray Liquid acts promptly to target and destroy fungus at the site of infection. FUNGICURE Pump Spray helps soothe and relieve itching, scaling, cracking, burning, redness, soreness, irritation and discomforts which may accompany fungus infection by eliminating the fungus...allowing for the natural regrowth of healthy skin.

PROMPT ACTION AND PROPER TREATMENT:

Recognizing and treating fungus infection early is very important for successful results, so 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 be continued uninterrupted, carefully following and adhering to package directions until satisfactory results are achieved or with further advice from a doctor. Factors such as product odor and ease of use are important in the encouragement of proper and continued use, therefore FUNGICURE Pump Spray Liquid is formulated to be easy to apply, fast drying, odorless and crystal clear. NOTE: Noticeable improvement may be expected within 4 weeks in the case of athlete's foot (tinea pedis) and ringworm (tinea corporis), two weeks for jock itch (tinea cruris). Consult your doctor for advice if noticeable improvement is not evident by this time or if condition persists or worsens.

HOW CAN YOU AVOID RECURRENCE OF FUNGUS INFECTION?

• Keep hands and feet meticulously clean and dry, as well as any areas of the body that may be normally covered by clothing which restricts air flow allowing moisture to build up. Fungus enjoys and thrives on moisture. 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, change shoes and wear clean socks daily.
• Avoid trimming cuticles and avoid cutting nails too close. Anything that tears or opens the skin invites fungus to invade. Be very observant for early signs of recurrence and don't hesitate to take prompt action with FUNGICURE Pump Spray Liquid following package directions carefully.

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 using. Use only as directed. Clean the affected area with soap and warm water and dry thoroughly. Apply (spray) a thin layer of FUNGICURE over the affected area twice daily (morning and night), or as directed by a doctor. 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. 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. This product is not effective on the scalp or nails.

Other Information: Serious side effects associated with the use of this product may be reported to the phone number provided below.

How Supplied: 63ml (2.1 fl. oz.) non-aerosol pump spray.

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

Questions? 1-800-792-2582