FDA.reportPublic FDA data

Tolnaftate 1% Cream Antifungal Cream

Manufacturer
Amerisource Bergen | Sun Pharma Canada Inc.
Effective date
2025-07-15
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:07:26

Label at a glance#

ProductTolnaftate Antifungal
Active ingredientTOLNAFTATE
Label structure11 sections

Indications and uses

cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis) helps prevent most athlete's foot with daily use for effective relief of itching scaling cracking burning redness soreness irritation discomfort

Dosage and administration

This product is not effective on the scalp or nails. For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks. clean the affected area and dry thoroughly apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor supervise children in the use of this product pay special attention to spaces between the toes; wear well-fitting, ...

Storage and handling

store at room temperature see carton or tube crimp for lot number and expiration date

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
  • helps prevent most athlete's foot with daily use
  • for effective relief of
    • itching
    • scaling
    • cracking
    • burning
    • redness
    • soreness
    • irritation
    • discomfort

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

For external use only

Ask a doctor before use

OTC - ASK DOCTOR SECTION

  • on children under 2 years of age

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot and ringworm) or within 2 weeks (for jock itch)

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

This product is not effective on the scalp or nails.

For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.

  • clean the affected area and dry thoroughly
  • apply a thin layer of the product over 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

SPL UNCLASSIFIED SECTION

pay special attention to spaces between the toes; wear well-fitting, ventilated shoes; change shoes and socks at least once daily

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature
  • see carton or tube crimp for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

BHT, PEG-400, PEG-3350, titanium dioxide, white petrolatum

Questions?

OTC - QUESTIONS SECTION

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Distributed By
AmerisourceBergen
1300 Morris Drive
Chesterbrook, PA 19087

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GOOD
NEIGHBOR
PHARMACY ®

Compare to the Tinactin ®active ingredient*

NDC 24385-032-03

Tolnaftate 1% Cream
Antifungal Cream

Cures & Prevents Most Athlete's Foot

NET WT 1 oz (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
103951tolnaftate 1 % Topical CreamPSN5
103951tolnaftate 10 MG/ML Topical CreamSCD5
103951tolnaftate 1 % Topical CreamSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24385-032-032020-06-23C16284748780-19d75b9d0-0f97-f424-e053-dadaa90a57ceTolnaftate 1% Cream Antifungal Cream
24385-032-032020-01-31C16284748780-19d75b9d0-0f97-f424-e053-dadaa90a57ceTolnaftate 1% Cream Antifungal Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24385-032-03TolnaftateAntifungal30 g in 1 TUBECREAM305
24385-032-03TolnaftateAntifungal1 in 1 CARTONCREAM15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24385-032-03GM - Gram24385-03208711039-a5d3-431b-9d16-7eb0349fde9d12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TolnaftateACTIVE INGREDIENT06KB629TKV2
TolnaftateACTIVE MOIETY06KB629TKV2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171K2
petrolatumINACTIVE INGREDIENT4T6H12BN9U2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQ2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JP2

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24385-03224385-032-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
PETROLATUM4T6H12BN9UIACT
TOLNAFTATE06KB629TKVACTIB

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 8 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQCREAM / TOPICAL10 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPCREAM / TOPICAL80 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPCREAM / TOPICAL80 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQCREAM / TOPICAL10 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
Tolnaftate AntifungalTOLNAFTATEAmerisource Bergena3c9b783-4a36-46b3-a0dc-0696907eaebb2025-07-15WarningsExact identifier
ndc (package): 24385-032-03
ndc (product): 24385-032
ndc11 (package): 24385003203
spl id: 39fb64e0-2510-e64b-e063-6294a90a89cb
spl set id: a3c9b783-4a36-46b3-a0dc-0696907eaebb

Reported adverse events (FAERS/openFDA)#

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