FDA.reportPublic FDA data

Tolnaftate

Manufacturer
CVS Pharmacy
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 20:45:23

Label at a glance#

ProductTolnaftate
Active ingredientTOLNAFTATE
Label structure9 sections

Indications and uses

proven clinically effective in the treatment of athlete's foot (tinea pedis) and ringworm (tinea corporis) prevents the recurrences of athlete's foot with daily use for effective relief of itching, burning, cracking, redness and scaling

Dosage and administration

Read all warnings and directions. Use only as directed. 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 toes wear well-fitting, ventilated shoes, and change shoes and socks at least once daily for ath...

Label contents#

Full prescribing information#

​Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1% w/w

​Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • proven clinically effective in the treatment of athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • prevents the recurrences of athlete's foot with daily use
  • for effective relief of itching, burning, cracking, redness and scaling

Warnings

WARNINGS SECTION

For external use only.

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 eyes.

Stop use and consult a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • there is no improvement in 4 weeks

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

​Directions

DOSAGE & ADMINISTRATION SECTION

Read all warnings and directions. Use only as directed.

  • 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 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 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 information​

OTHER SAFETY INFORMATION

  • 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

INACTIVE INGREDIENT SECTION

Water, Acrylates Copolymer, Glycerin (RSPO), Phenoxyethanol, Tocopherol, Sodium Hydroxide, Ethylhexyglycerin

Questions?

OTC - QUESTIONS SECTION

Call 1-866-964-0939

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAXIMUM

STRENGTH

Toe Area

Treatment

Antifungal Liquid

TOLNAFTATE

  • Treats the growth of fungus on fingers & toes
  • Easy brush application
  • Dries quickly with no unpleasant odor

NET 1 FL OZ (30 mL)

AF Liquid Toe Area TreatmentAF Liquid Toe Area Treatment

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-274TOLNAFTATE (TOE AREA TREATMENT) LIQUID [CVS PHARMACY]8Legacy NDC20241220_b5c47dd0-9ac9-07ad-e053-2995a90a1afd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-274-01ML - Milliliter69842-274b23f871d-c2d3-493b-9851-59fc86b5d82712023-12-05

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-27469842-274-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
TOCOPHEROLR0ZB2556P8IACT
TOLNAFTATE06KB629TKVACTIB
ETHYLHEXYLGLYCERIN147D247K3PIACT

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
298f6219-ef57-0aca-e063-6294a90ad434b5c47dd0-9ac9-07ad-e053-2995a90a1afd2024-12-18WarningsExact identifier
spl id: 298f6219-ef57-0aca-e063-6294a90ad434
spl set id: b5c47dd0-9ac9-07ad-e053-2995a90a1afd

Reported adverse events (FAERS/openFDA)#

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