FDA.reportPublic FDA data

Fungistat Max

Manufacturer
Bio-Medical & Pharmaceutical Manufacturing Corporation
Effective date
2016-04-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:45:41

Label at a glance#

ProductFungistat Max
Active ingredientCLOTRIMAZOLE
Label structure9 sections

Dosage and administration

Wash the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. The brush applicator allows easy application under the nails and surrounding cuticle area. Always use well-ventilated shoes and change socks at least once each day. Supervise children in the use of this product. For Athlete’s Foot: Pay special attention to the ...

Label contents#

Full prescribing information#

Drug Facts

DESCRIPTION SECTION

Fungistat topical antifungal liquid.

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole 1.0%

Purpose

OTC - PURPOSE SECTION

Antifungal

Indications

INDICATIONS & USAGE SECTION

  • Cures most tinea pedis (athlete's foot), tinea cruris (jock itch), and tinea corporis (ringworm).
  • Relieves itching, burning feet and itching, scaling, cracking, burning, redness, soreness, irritation, discomfort, and chafing associated with jock itch.
  • Clears up most athlete’s foot infection and with daily use helps keep it from coming back.

Warnings

WARNINGS SECTION

  • Do not use on children under 2 years of age unless directed by a doctor.
  • For external use only.
  • Avoid contact with the eyes.
  • For Athlete’s Foot: If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.
  • For Jock Itch: If irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a doctor.
  • Do not use for diaper rash.
  • Flammable – Do not use near open flame or heat source.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wash the affected area and dry thoroughly.
  • Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor.
  • The brush applicator allows easy application under the nails and surrounding cuticle area.
  • Always use well-ventilated shoes and change socks at least once each day.
  • Supervise children in the use of this product.
  • For Athlete’s Foot: Pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes, and changes shoes and socks at least once daily.
  • For Athlete’s Foot & Ringworm: Use daily for 4 weeks.
  • If condition persists longer, consult a doctor.
  • This product is not effective on the scalp or nails.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Isopropyl Alcohol, Polysorbate 80, Arnica Montana, Methyl Ethyl Ketone, Sodium Lauryl Sulfate, Undecylenic Acid, Peppermint Oil, Salicylic Acid, Sodium Propionate, Sorbic Acid, Propionic Acid, Thymol, Aloe Vera Leaf.

Questions or Comments

OTC - QUESTIONS SECTION

Bio-Medical & Pharmaceutical Mfg. Corp.

4311 South Dr.

Houston, TX 77053-4820

Phone: 281.835.8051 M-F 8am-5pm

Internet: www.kleerplex.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Kleer-Plex

PROFESSIONAL FUNGISTAT MAX

1% Clotrimazole Transdermal Liquid

NDC 37945-908-13

Contains 1 fl. oz.

Cures Fungal Infections Fast

Maximum Strenth OTC Liquid

Safe & Effective Prescription Alternative

FungistatFungistat

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309370clotrimazole 1 % Topical SolutionPSN1
1747489FUNGISTAT MAX 1 % Topical SolutionPSN1
1747489clotrimazole 10 MG/ML Topical Solution [Fungistat]SBD1
309370clotrimazole 10 MG/ML Topical SolutionSCD1
309370clotrimazole 1 % Topical SolutionSY1
1747489Fungistat 10 MG/ML Topical SolutionSY1
1747489Fungistat Max 1 % Topical SolutionSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37945-908-122020-01-31C16284748780-19d75b9d0-fc31-f424-e053-dadaa90a57ce2fc20e9c-c95a-6a41-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37945-908-12Fungistat Max1 in 1 BOXLIQUID11
37945-908-13Fungistat Max30 mL in 1 BOTTLELIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37945-908FUNGISTAT MAX (CLOTRIMAZOLE TRANSDERMAL LIQUID) LIQUID [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]1Legacy NDC, 2 package rows20160412_2fc20e9c-c95a-6a41-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37945-90837945-908-13, 37945-908-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
CLOTRIMAZOLEG07GZ97H65ACTIB
WATER059QF0KO0RIACT
POLYSORBATE 806OZP39ZG8HIACT
ARNICA MONTANAO80TY208ZWIACT
UNDECYLENIC ACIDK3D86KJ24NIACT
PEPPERMINT OILAV092KU4JHIACT
SALICYLIC ACIDO414PZ4LPZIACT
SODIUM PROPIONATEDK6Y9P42INIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SORBIC ACIDX045WJ989BIACT
PROPIONIC ACIDJHU490RVYRIACT
THYMOL3J50XA376EIACT
ALOE VERA LEAFZY81Z83H0XIACT
ISOPROPYL ALCOHOLND2M416302IACT
METHYL ETHYL KETONE6PT9KLV9IOIACT

Source Document#

Source XML

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
2fc20e9c-c95b-6a41-e054-00144ff8d46c2fc20e9c-c95a-6a41-e054-00144ff8d46c2016-04-05WarningsExact identifier
spl id: 2fc20e9c-c95b-6a41-e054-00144ff8d46c
spl set id: 2fc20e9c-c95a-6a41-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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