MedPath
FDA Approval

Fungazol Athlete Foot

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Rida LLC
DUNS: 004425803
Effective Date
May 28, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Miconazole(2 g in 100 mL)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Fungazol Athlete Foot

Product Details

NDC Product Code
83004-025
Application Number
M005
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
TOPICAL
Effective Date
May 28, 2025
TEA TREE OILInactive
Code: VIF565UC2GClass: IACT
BENZOIC ACIDInactive
Code: 8SKN0B0MIMClass: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCNClass: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJSClass: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4MClass: IACT
OLIVE OILInactive
Code: 6UYK2W1W1EClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1YClass: IACT
Code: VW4H1CYW1KClass: ACTIBQuantity: 2 g in 100 mL

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product label

image description


INDICATIONS & USAGE SECTION

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 & ADMINISTRATION SECTION

Directions

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) for1 weekor as directed by doctor *on the bottom or sides of the foot: apply twice a day (morning and night) for2 weeksor as directed by doctor *for jock itch and ringworm: apply once a day (morningornight) for1 weekor as directed by a doctor
  • wash hands after each use
  • Children under 12 years: ask a doctor

WARNINGS SECTION

Warnings

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 productdo not get into eyes. If eye contact occurs, rinse thoroughly with water.

Stop use and ask a doctor iftoo 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.


OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Miconazole Nitrate USP, 2%

OTC - PURPOSE SECTION

Purpose

Antifungal

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


SPL UNCLASSIFIED SECTION

Questions or comments?

(888) 885-6137

INACTIVE INGREDIENT SECTION

Inactive ingredients

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


© Copyright 2025. All Rights Reserved by MedPath