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Fungicure Maximum Strength by Alva-Amco Pharmacal Companies, Inc.

Dosage form: liquid
Ingredients: Undecylenic acid 250mg in 1mL
Labeler: Alva-Amco Pharmacal Companies, Inc.
NDC Code: 52389-198

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 Facts

Active Ingredient

Undecylenic acid 25% w/v

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



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 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.
  • This product is not effective on scalp or nails.
  • 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 ingredient

Isopropyl palmitate

Questions? 1-800-792-2582

Fungicure Maximum Strength Liquid Insert

Maximum Strength FUNGICURE Anti-Fungal Liquid

Kills 6 types of fungus on fingers and toes including around nails where reachable with applicator brush.

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.

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 Anti-Fungal Liquid, 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 WORKS:

MAXIMUM STRENGTH FUNGICURE Liquid contains undecylenic acid, 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 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 and discuss its use. For best results, once treatment is started with FUNGICURE Liquid, 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 ringworm and athlete's foot fungus. Consult your doctor for advice if noticeable improvement is not evident by this time or if the condition persists or worsens.

Active ingredient: Undecylenic Acid 25% w/v

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 over the affected area (including the exposed nailbed) twice daily (morning and night), or as directed by a doctor.  This product is not effective on scalp or nails.  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: While not all finger and toe fungal infection 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 palmitate.

Questions? 1-800-792-2582

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.

FUNGICURE  MAXIMUM STRENGTH
undecylenic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: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
ISOPROPYL PALMITATE 
Packaging
#Item CodePackage Description
1NDC:52389-198-3030 mL in 1 BOTTLE, WITH APPLICATOR
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: 08/2015
 
Alva-Amco Pharmacal Companies, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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