Fungicure description, usages, side effects, indications, overdosage, supplying and lots more!

Fungicure

Alva-Amco Pharmacal Companies, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient

Undecylenic acid 12.5% 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

You may report serious side effects to the phone number provided under Questions? below.

Inactive ingredients

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

Questions? 1-847-663-0700

Fungicure Professional Formula Insert

FUNGICURE Anti-Fungal Liquid

Topical Formula

STOPS FUNGUS

On skin around and adjacent to nails

The Finger and Toe Fungi Specialist

  • Easy Brush-on
  • Quick Drying
  • No Medicinal Odour
  • Contains Aloe and Vitamin E

A WORD ABOUT FUNGICURE ANTI-FUNGAL LIQUID:

With your purchase of FUNGICURE, you have chosen a highly effective and remarkably convenient treatment for common fungus infection of the finger and toe areas, including on skin around and adjacent to 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 where the infection is, avoiding the mess and excess spreading of creams, ointments or "drop on" liquids... Furthermore, with FUNGICURE your fingers need never touch affected areas. FUNGICURE is a crystal clear liquid which dries fast without messy residue or medicinal odour.

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. 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 infections may present themselves on the skin as ring like formations with clear centers, commonly referred to as ringworm. Other such infections, when on the skin or finger and toe areas, are often characterized by scaling of skin, burning, cracking, itching and related discomforts. 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:

Undecylenic acid in FUNGICURE 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, on and between the fingers and toes, including the skin and cuticle around the nails.

HOW TO AVOID RECURRENCE OF FUNGUS INFECTION:

  • 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.
  • In cases where athlete's foot (tinea pedis) has been a problem, wear well ventilated shoes and change to clean socks daily.
  • Avoid any practices that can tear or bruise the skin. Avoid trimming 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 following package directions carefully.

Indications: For the cure of ringworm (tinea corporis) and athlete's foot (tinea pedis) affecting finger and toe areas. For relief of:  itching, scaling, cracking, burning, redness, soreness, irritation and discomforts which may accompany these conditions.

Directions:  Clean the affected area with soap and warm water and dry thoroughly.  Apply a thin layer of FUNGICURE over affected area twice daily (morning and night), or as directed by a doctor. Supervise children in the use of this product.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.  This product is not effective on scalp or nails.

Active ingredient: Undecylenic acid.

Other ingredients Aloe vera gel, fragrance, glacial acetic acid*, hypromellose, isopropyl alcohol, purified water, vitamin E.
*May contain.

Warnings:  For external use only. Read all package directions and warnings before use. Use only as directed. 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. Do not use on children under two years of age unless directed by a doctor. Avoid contact with the eyes. If irritation occurs, or if there is no improvement with 4 weeks, discontinue use and consult a doctor.

Contents sealed: Each bottle of Fungicure Anti-Fungal Liquid is sealed closed with a band around the cap. Do not use if seal is broken or missing.

Do not use for infection of the scalp. Keep this and all medications out of reach of children. In case of accidental ingestion, contact a physician, emergency medical care facility or poison control center immediately for advice.

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

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

fungicure.com

Fungicure

Undecylenic Acid LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:52389-168
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
UNDECYLENIC ACID 125 mg

Inactive Ingredients

Ingredient Name Strength
Aloe Vera Leaf
HYPROMELLOSES
ISOPROPYL ALCOHOL
water
.ALPHA.-TOCOPHEROL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BOTTLE, WITH APPLICATOR
2 NDC:52389-168-30 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partC part333C 2005-01-27


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