FDA.reportPublic FDA data

Fungazol Athlete Foot

Manufacturer
Rida LLC
Effective date
2025-05-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:01:42

Label at a glance#

ProductFungazol Athlete Foot
Active ingredientMICONAZOLE NITRATE
Label structure9 sections

Indications and uses

cures most athlete’s foot (tinea pedis) cures most jock itch (tinea cruris) and ringworm (tinea corporis) relieves itching, burning, cracking and scaling which accompany theses conditions

Dosage and administration

Adults and children 12 years and over: wash affected area with soap and water and dry completely before applying for athlet's foo t wear well-fitting, ventilated shoes. Change shoes and socks at least once daily. between the tose only: apply twice a day (morning and night) for 1 week or as directed by doctor on the bottom or sides of the foot:  apply twice a day (morning and night) for 2 weeks or as directed by do...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate USP, 2%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • cures most athlete’s foot (tinea pedis)
  • cures most jock itch (tinea cruris) and ringworm (tinea corporis)
  • relieves itching, burning, cracking and scaling which accompany theses conditions

Warnings

WARNINGS SECTION

For external use only

Do not use

  • on nails or scalp
  • in or near the mouth or eyes
  • for vaginal yeast infections

When using this product do not get into eyes. If eye contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if too much irritation occurs or gets worse.

Keep out of the reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and over:

  • wash affected area with soap and water and dry completely before applying
  • for athlet's foo twear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
  • between the tose only:apply twice a day (morning and night) for 1 weekor as directed by doctor
  • on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeksor as directed by doctor
  • for jock itch and ringworm: apply once a day (morning ornight) for 1 weekor as directed by a doctor
  • wash hands after each use
  • Children under 12 years: ask a doctor

Other Information 

SPL UNCLASSIFIED SECTION

  • do not use if seal on the tube is broken or is not visible. 
  • store at controlled room temperature 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Organic tea tree oil, benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, olive oil, potassium hydroxide, propylene glycol, water, stearyl alcohol

Questions or comments?

SPL UNCLASSIFIED SECTION

(888) 885-6137

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998483miconazole nitrate 2 % Topical CreamPSN1
998483miconazole nitrate 20 MG/ML Topical CreamSCD1
998483miconazole nitrate 2 % Topical CreamSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83004-025-012025-08-20C16284748780-13b156c62-271e-fb37-e063-e6dba90a4e07ce60e1ec-a69b-4b98-a2b2-105e9cd37bc7
83004-025-012025-07-29C16284748780-13b156c62-271e-fb37-e063-e6dba90a4e07ce60e1ec-a69b-4b98-a2b2-105e9cd37bc7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83004-025-01Fungazol Athlete Foot1 in 1 CARTONCREAM11
83004-025-01Fungazol Athlete Foot120 mL in 1 BOTTLECREAM1201

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83004-02583004-025-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
TEA TREE OILVIF565UC2GIACT
BENZOIC ACID8SKN0B0MIMIACT
CETYL ALCOHOL936JST6JCNIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
POLYSORBATE 60CAL22UVI4MIACT
OLIVE OIL6UYK2W1W1EIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
STEARYL ALCOHOL2KR89I4H1YIACT
MICONAZOLE NITRATEVW4H1CYW1KACTIB

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
Fungazol Athlete FootMICONAZOLE NITRATERida LLCce60e1ec-a69b-4b98-a2b2-105e9cd37bc72025-05-28WarningsExact identifier
ndc (package): 83004-025-01
ndc (product): 83004-025
ndc11 (package): 83004002501
spl id: 3632e06d-9a9b-ca67-e063-6394a90ab6e8
spl set id: ce60e1ec-a69b-4b98-a2b2-105e9cd37bc7