MedPath

Antifungal Solution Maximum Strength

Rite Aid Anti-fungal Solution

Approved
Approval ID

13a49826-f368-95f8-e063-6394a90adc4b

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 21, 2025

Manufacturers
FDA

Rite Aid Corporation

DUNS: 014578892

Products 1

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

Tolnaftate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code11822-9600
Application NumberM005
Product Classification
M
Marketing Category
C200263
G
Generic Name
Tolnaftate
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 21, 2025
FDA Product Classification

INGREDIENTS (8)

PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
BETASIZOFIRANInactive
Code: 2X51AD1X3T
Classification: IACT
TOLNAFTATEActive
Quantity: 10 mg in 1 mL
Code: 06KB629TKV
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 4/6/2021

Principal Display Panel

MAXIMUM STRENGTH

Anti-fungal Solution

Tolnaftate 1%

Proven clinically effective in the treatment of fungus on fingers, toes & skin around nails

Prevents the recurrence of most athlete's foot with daily use

Relieves itching, burning & scaling

Built-in brush for easy application

With moisturizing ingredients

SHAKE WELL BEFORE USE

1 FL. OZ. (30 mL)

Unit Carton

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 10/1/2020

Uses

proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)

prevents the recurrence of most athlete's foot with daily use

for effective relief of itching, burning, cracking, redness and scaling

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 10/1/2020

​Active ingredient

Tolnaftate 1%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 10/1/2020

​Purpose

Antifungal

WARNINGS SECTION

LOINC: 34071-1Updated: 8/21/2014

Warnings

For external use only.

Do not use

on children under 2 years of age unless directed by a doctor.

When using this product

avoid contact with the eyes.

Stop use and consult a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks

Keep out of reach of children.

If accidental ingestion occurs, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 10/1/2020

​Directions

  • clean the affected area and dry thoroughly
  • apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor
  • supervise children in the use of this product
  • for athlete's foot: pay special attention to spaces between the 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
  • to prevent athlete's foot: wash the feet and dry thoroughly; apply a thin layer of the product to the feet once or twice daily (morning and/or night)
  • this product is not effective on the scalp or nails

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 10/1/2020

​Other information

  • SHAKE WELL BEFORE USE
  • store at room temperature 15°-30°C (59° - 86°F)
  • protect from freezing; if freezing occurs, warm to room temperature
  • keep tightly closed when not in use

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 10/1/2020

​Inactive ingredient

Disodium EDTA, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Sclerotium Gum, Water, Xanthan Gum

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 10/1/2020

Questions?

Call 1-866-964-0939

RECENT MAJOR CHANGES SECTION

LOINC: 43683-2Updated: 3/12/2024

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.