Fungicure Liquid Gel

Manufacturer
Kobayashi Healthcare International, Inc. | Kobayashi America Manufacturing
Effective date
2025-10-21
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:40:41

Label at a glance#

ProductFungicure Liquid Gel
Active ingredientCLOTRIMAZOLE
Label structure14 sections

Indications and 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.

Dosage and administration

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 ringworm and athlete's foot, use daily for 4 week...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole 1% w/w

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only

OTC - ASK DOCTOR SECTION

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

OTC - WHEN USING SECTION

When using this product avoid contact with eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION


  • Irritation occurs
  • There is no improvement within 4 weeks.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 ringworm and athlete's foot, use daily for 4 weeks. If condition persists longer, consult 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.
  • 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

INFORMATION FOR PATIENTS SECTION

  • Fungicure may be applied to exposed nail-beds, 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

INACTIVE INGREDIENT SECTION

Hydroxypropylcellulose and isopropyl alcohol.

OTC - QUESTIONS SECTION

Questions? 1-800-792-2582

Fungicure Maximum Strength Liquid Gel Insert

SPL PATIENT PACKAGE INSERT SECTION

Maximum Strength FUNGICURE Liquid Gel

Anti-Fungal Treatment

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

WHAT IS FUNGUS INFECTION OF THE FINGER AND TOE AREAS?

Common fungus infections of the fingers 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 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 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 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 fungus 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 ringworm and athlete's foot fungus. 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 (including the exposed nail bed) 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: 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 ingredients Hydroxypropylcellulose and Isopropyl alcohol.

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FungicureLiquidGelPDPFungicureLiquidGelPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049535clotrimazole 1 % Topical GelPSN9
1049535clotrimazole 0.01 MG/MG Topical GelSCD9
1049535clotrimazole 1 % Topical GelSY9

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CLOTRIMAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130072959015336GTIN-13: 0072959015336
EAN-13: 0072959015336
GTIN-12: 072959015336
UPC-A: 072959015336
GTIN storage (14 digits): 00072959015336
Fungicure Liquid Gel 133-09-9RC.jpg
Data codeCode 12811335009RC9Fungicure Liquid Gel 133-09-9RC.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52389-733-09Fungicure Liquid Gel1 in 1 BOXGEL19
52389-733-09Fungicure Liquid Gel9 g in 1 TUBE, WITH APPLICATORGEL99

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52389-73352389-733-09

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82024-05-08full-release2026-06-01 00:12:16

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fungicure Liquid GelCLOTRIMAZOLEKobayashi Healthcare International, Inc.dfd03852-29bd-4e16-97f3-64dfde5f8ff82025-10-21WarningsExact identifier
ndc (package): 52389-733-09
ndc (product): 52389-733
ndc11 (package): 52389073309
spl id: 41ae836c-6a1d-e223-e063-6394a90ae05a
spl set id: dfd03852-29bd-4e16-97f3-64dfde5f8ff8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.