FDA Label for Fungicure Manicure Pedicure Liquid Gel

Active Ingredient

Clotrimazole 1% w/w

Purpose

Antifungal

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

For external use only

Otc - Ask Doctor

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

Otc - When Using

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.

Otc - 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.

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 over the affected area twice daily (morning and night), or as directed by a doctor.
• This product is not effective on 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 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.
  

Inactive Ingredients

Hydroxypropylcellulose and isopropyl alcohol.

Otc - Questions

Questions? 1-800-792-2582

Fungicure Maximum Strength Liquid Gel Insert

Maximum Strength FUNGICURE Liquid Gel

Anti-Fungal Treatment

Manicure & Pedicure Professional Formula

Kills ugly fungus for healthy looking fingers & toes

Odor free and instant dry

Liquid Gel locks onto site of infection

The Manicure & Pedicure Fungi Specialist

Maintaining the appearance of your manicure and pedicure requires more than cosmetics. Fungicure Liquid Gel is a maximum strength anti-fungal, specifically formulated for those who manicure, pedicure or use artificial nails, including manicure and nail care professionals. Fungicure's precision QuickBrush applicator allows for easy application to the site of hard to reach infections, including under nail tips.

WHAT IS FUNGUS INFECTION OF THE FINGER AND TOES?

Common fungus infections of the finger 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.

Many manicure procedures can enhance the risk of fungal infection. Certain types of artificial nails can trap moisture and fungi, creating a perfect environment for fungus to grow and spread. Cutting cuticles can create opportunities for fungal infections. Promptly treating a fungal infection on cuticle and nearby sin surfaces reduces the risk of it spreading.

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, when in the finger and toe areas, is 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 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 intact; they may be missing, cracked open, or lifted away, exposing the infected nail bed. In these instances FUNGICURE Liquid Gel, 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 LIQUID GEL WORKS:

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

When applied as directed, FUNGICURE Liquid Gel 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 Liquid Gel and discuss its use. For best results, once treatment is started with FUNGICURE Liquid Gel, 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). Consult your doctor for advice if noticeable improvement is not evident by this time or if condition persists or worsens.

Active Ingredient: Clotrimazole 1% w/w

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 use. 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 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. 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 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 ingredients Hydroxypropylcellulose and Isopropyl alcohol.

Questions? 1-800-792-2582

www.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.