FDA.reportPublic FDA data

Athletes Foot

Manufacturer
CVS Pharmacy
Effective date
2016-11-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:21:35

Label at a glance#

ProductAthletes Foot
Active ingredientTOLNAFTATE
Label structure9 sections

Indications and uses

• proven clinically effective in the treatment of most athlete’s foot (tinea pedis) and ringworm (tinea corporis) • helps prevent most athlete’s foot with daily use • for effective relief of itching, burning and cracking

Dosage and administration

• wash affected area and dry thoroughly • shake can well and spray a thin layer over affected area twice daily (morning and night) • 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 • use daily for 4 weeks; if condition persists longer, ask a doctor • to prevent at...

Storage and handling

• store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • proven clinically effective in the treatment of most athlete’s foot (tinea pedis) and ringworm (tinea corporis)
  • helps prevent most athlete’s foot with daily use
  • for effective relief of itching, burning and cracking

Warnings

WARNINGS SECTION

For external use only

Flammable: Do not use while smoking or near heat or flame

Do not use

OTC - DO NOT USE SECTION

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

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes
  • use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.
  • contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F (49°C).

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • there is no improvement within 4 weeks

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • wash affected area and dry thoroughly
  • shake can well and spray a thin layer over affected area twice daily (morning and night)
  • 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
  • use daily for 4 weeks; if condition persists longer, ask a doctor
  • to prevent athlete’s foot, apply once or twice daily (morning and/or night)
  • this product is not effective on the scalp or nails

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol denat., butylated hydroxytoluene, isobutane, polyethylene glycol 300, polysorbate 20

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient in Tinactin®

Liquid Spray

Antifungal

Athlete’s Foot

Liquid Spray

TOLNAFTATE 1%

Cures & prevents most athlete’s foot

Relieves itching & burning

NET WT 5.3 OZ (150 g)

Athlete's Foot Label
Athlete's Foot Label

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-15469842-154-73

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
TOLNAFTATE06KB629TKVACTIB
ALCOHOL3K9958V90MIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
ISOBUTANEBXR49TP611IACT
POLYETHYLENE GLYCOL 3005655G9Y8AQIACT
POLYSORBATE 207T1F30V5YHIACT

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
5207d9ad-d17f-4fc3-b048-9b5ca21f9c1fa8d9edb1-e28b-412e-9fc0-939b0d58c26f2020-10-26WarningsExact identifier
spl set id: a8d9edb1-e28b-412e-9fc0-939b0d58c26f

Reported adverse events (FAERS/openFDA)#

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