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Fungicure

Dosage form: gel
Ingredients: Tolnaftate 10mg in 1g
Labeler: Alva-Amco Pharmacal Companies, Inc.
NDC Code: 52389-162

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

Tolnaftate, 1% w/w....................................Antifungal

Uses

For the cure of most:

  • athlete's foot (tinea pedis)
  • ringworm (tinea corporis)
  • jock itch (tinea cruris)

For the relief of:

  • itching
  • scaling
  • cracking
  • burning
  • redness
  • soreness
  • irritation
  • and discomforts which may accompany these conditions.

Proven effective in the prevention of most athlete's foot with daily use.  Clears up most athlete's foot infection and with daily use ehlps keep it from coming back.

WarningsFor 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 (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 a thin layer of Fungicure Gel 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 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 on the scalp or nails.

Other information

Keep container tightly closed when not in use.  Store away from excessive heat and cold.

Aloe vera gel, hydroxypropyl cellulose, isopropyl alcohol, polyethylene glycol, propylene glycol and vitamin E.

FUNGICURE Anti-Fungal Gel

Stops Fungus:  Most Athlete's Foot, Ringworm, Jock Itch

  • Crystal Clear Topical Formula
  • Odorless
  • Fast Drying
  • Greaseless
  • Quick Absorbing
  • Contains Aloe and Vitamin E
  • Doctor Recommended

A Word About FUNGICURE Anti-Fungal Gel:

With your purchase of FUNGICURE Gel, you have chosen a highly effective and convenient treatment for common fungus infection ... specifically most athlete's foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris). FUNGICURE is a crystal clear, odorless gel which delivers a highly effectiveanti-fungal ingredient directly to the site of infection. FUNGICURE Gel dries fast, absorbs quickly without messy residue or medicinal odor.

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. 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 Gel and discuss its use.

How Fungicure Gel Works; Product Description and Action:

FUNGICURE Gel is an effective topical formulation containing the ACTIVE INGREDIENT: Tolnaftate (1 % w/w) INACTIVE INGREDIENTS: Aloe vera gel, hydroxypropyl cellulose, Isopropyl alcohol, polyethylene glycol, propylene glycol, vitamin E. Tolnaftate In FUNGICURE Gel is widely recognized by doctors to be an 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.

Prompt Action and Proper Treatment:

FUNGICURE Gel acts promptly to target and destroy fungus at the site of infection. FUNGICURE Gel helps 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. With continued use, FUNGICURE Gel helps prevent fungus infection from coming back. NOTE: Noticeable improvement may be expected within 4 weeks in the case of athlete's foot (tinea pedis) and ringworm (tinea corporis) and 2 weeks in the case of jock itch (tinea cruris). Consult your doctor tor advice it noticeable improvement is not evident by this time or if condition persists or worsens.

How Can You Avoid Recurrence of Fungus Infection?

  1. 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.
  2. In cases where athlete's foot (tinea pedis) has been a problem, wear well ventilated shoes and change to clean socks daily.
  3. In cases where jock itch (tinea cruris) has been a problem, wear loose or well ventilated garments whenever possible and change garments which come in contact with infected areas at least daily.
  4. 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:  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. Proven effective in the prevention of most athlete's foot with daily use. Clears up most athlete's foot infection and with daily use helps keep it from coming back.

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 (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 a thin layer of FUNGICURE Gel 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 dally. 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.  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.

How Supplied: 0.6 ounce (17g) tube.

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


FUNGICURE 
tolnaftate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52389-162
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Tolnaftate (Tolnaftate) Tolnaftate10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Isopropyl alcohol 
Polyethylene glycol 600 
Polyethylene glycol 400 
Propylene glycol 
Hydroxypropyl cellulose 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
Aloe vera leaf 
Packaging
#Item CodePackage Description
1NDC:52389-162-1717 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C10/01/1994
Labeler - Alva-Amco Pharmacal Companies, Inc. (042074856)

Revised: 05/2010
 
Alva-Amco Pharmacal Companies, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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