FUNGICURE MAXIMUM STRENGTH - undecylenic acid liquid 
Alva-Amco Pharmacal Companies, Inc.

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Drug Facts

Active Ingredients

Undecylenic acid 25% w/v...........................................Antifungal

Uses

For the cure of most

For relief of

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


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

Inactive ingredients

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

Questions? 1-800-792-2582

Fungicure Maximum Strength Liquid Insert

Maximum Strength FUNGICURE Anti-Fungal Liquid

Topical Formula

The Finger and Toe Fungi Specialist

A WORD ABOUT MAXIMUM STRENGTH FUNGICURE ANTI-FUNGAL LIQUID:

With your purchase of doctor recommended FUNGICURE Liquid, you have chosen a highly effective and remarkably convenient treatment for common fungus infection of the finger and toe areas including on skin around, adjacent to and under the nails where normally accessible with the FUNGICURE applicator brush. FUNGICURE's convenient applicator brush allows for controlled, easily targeted application so medicine may be applied directly and neatly to the site of infection. With FUNGICURE your fingers need never touch affected areas. FUNGICURE liquid 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 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 among body parts...one toe to another...or finger to finger. 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 and treated appropriately with an effective anti-fungal medicine.

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 and discuss its use.

HOW FUNGICURE LIQUID WORKS; PRODUCT DESCRIPTION AND ACTION:

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

Undecylenic acid in FUNGICURE Liquid is a widely recognized, proven 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, on and between the fingers and toes including the skin around the nails.

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

WHY FUNGICURE 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 thought 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 around and adjacent to the nail plate, at the very edges, 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, 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 eliminates the fungus, and in so doing, allows for the re-growth of healthy nail bed and nail plate tissue.

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 is to be continued uninterrupted, carefully following and adhering to package directions until satisfactory results are achieved or with further advice from a doctor.

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. Keep hands and feet meticulously clean and dry, since fungus enjoys and thrives on moisture. 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 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 over the affected area twice daily (morning and night), or as directed by a doctor.  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 ringworm and athlete's foot, 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.  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.

Questions? 1-800-792-2582

How Supplied: 1 fluid ounce (30 ml) bottle with brush applicator.

Storage: Keep tightly closed when not in use. Store away from excessive heat orcoid

Fungicure Maximum Strength Principal Display Panel


FUNGICURE  MAXIMUM STRENGTH
undecylenic acid   liquid
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)52389-198
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Undecylenic acid (Undecylenic acid) Undecylenic acid250 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Aloe vera leaf 
Hypromellose 
Isopropyl alcohol 
Water 
Vitamin E 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
152389-198-3030 mL In 1 BOTTLE, WITH APPLICATORNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/27/2005

Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)
Revised: 05/2010Alva-Amco Pharmacal Companies, Inc.