FDA.reportPublic FDA data

Tolnaftate Antifungal

Manufacturer
STRATEGIC SOURCING SERVICES LLC | Sun Pharma Canada Inc.
Effective date
2025-07-15
Label type
HUMAN OTC DRUG LABEL
Version
3
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

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 apply 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 twi...

Storage and handling

store between 20° to 25°C (68° to 77°F) 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

  • 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

OTC - WHEN USING SECTION

When using this productavoid contact with the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • there is no improvement within 4 weeks

OTC - DO NOT USE SECTION

Do not useon children under 2 years of age except under the advice and supervision of a doctor.

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

  • wash affected area and dry thoroughly
  • apply 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 between 20° to 25°C (68° to 77°F)
  • 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 833-358-6431

SPL UNCLASSIFIED SECTION

Distributed by:McKesson Corp.,
via Strategic Sourcing Services LLC.
Memphis, TN 38141

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Foster & Thrive™

Antifungal Cream

Tolnaftate Cream 1%
ANTIFUNGAL

NET WT ½ OZ (15 g)

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
103951tolnaftate 1 % Topical CreamPSN3
103951tolnaftate 10 MG/ML Topical CreamSCD3
103951tolnaftate 1 % Topical CreamSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1001-1Tolnaftate Antifungal1 in 1 CARTONCREAM13
70677-1001-1Tolnaftate Antifungal15 g in 1 TUBECREAM153

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1001-1GM - Gram70677-1001f4c6e659-e4d5-4eb6-bc23-21fbb4a674f212023-10-16

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
70677-100170677-1001-1

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
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POLYETHYLENE GLYCOL 3350G2M7P15E5PIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
PETROLATUM4T6H12BN9UIACT
TOLNAFTATE06KB629TKVACTIB

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
Tolnaftate AntifungalTOLNAFTATESTRATEGIC SOURCING SERVICES LLC97ffb6fd-5670-4783-b805-88fe9e43ca962025-07-15WarningsExact identifier
ndc (package): 70677-1001-1
ndc (product): 70677-1001
ndc11 (package): 70677100101
spl id: 39fad608-a813-37da-e063-6394a90acc98
spl set id: 97ffb6fd-5670-4783-b805-88fe9e43ca96

Reported adverse events (FAERS/openFDA)#

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