FDA.reportPublic FDA data

Tolnaftate

Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-06-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:14:32

Label at a glance#

ProductTolnaftate
Active ingredientTOLNAFTATE
Label structure10 sections

Indications and uses

for effective treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis) for effective relief of itchy, scaly skin between the toes clears up most athlete's foot infection and with daily use helps keep it from coming back

Dosage and administration

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 use daily for 4 weeks. If condition persists longer, consult a doctor pay special attention to the spaces between the toes wear well fitting ventilated shoes change shoes and socks at least onc...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate USP 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • for effective treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
  • for effective relief of itchy, scaly skin between the toes
  • clears up most athlete's foot infection and with daily use helps keep it from coming back

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
OTC - WHEN USING SECTION

When using this product avoid contact with eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Keep this and all drugs out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

  • use daily for 4 weeks. If condition persists longer, consult a doctor
  • pay special attention to the spaces between the toes
  • wear well fitting ventilated shoes
  • change shoes and socks at least once daily

For ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.

For jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor.

This product is not effective on the scalp or nails.

Other information

SPL UNCLASSIFIED SECTION

  • Store at controlled room temperature 15°-30°C (59°-86°F)
  • Lot No. and Exp date: see crimp on tube or see box

Inactive ingredients

INACTIVE INGREDIENT SECTION

Ceteth-20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, Propylene Glycol, Purified Water, Sodium Phosphate Monobasic, White Petrolatum

Questions?

OTC - QUESTIONS SECTION

Adverse Drug Event call (800)616-2471

Dist. By MAJOR PHARMACEUTICALS, 31778 Enterprise Drive, Livonia, MI 48150 USA

Re-Oder No. 100497 M-88 Rev. 9/09 Manufactured in USA

Principal Display Panel –

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
103951tolnaftate 1 % Topical CreamPSN4
103951tolnaftate 10 MG/ML Topical CreamSCD4
103951tolnaftate 1 % Topical CreamSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4245-52024-06-30C16284748780-1ba0f9c33-1f3d-a910-e053-dadaa90a0b8563665de7-8415-651f-e053-2991aa0ac2bb
68071-4245-52023-01-30C16284748780-1ba0f9c33-1f3d-a910-e053-dadaa90a0b8563665de7-8415-651f-e053-2991aa0ac2bb
68071-4245-52021-02-16C16284748780-1ba0f9c33-1f3d-a910-e053-dadaa90a0b8563665de7-8415-651f-e053-2991aa0ac2bb
68071-4245-52021-01-29C16284748780-1ba0f9c33-1f3d-a910-e053-dadaa90a0b8563665de7-8415-651f-e053-2991aa0ac2bb

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4245-5Tolnaftate14.18 g in 1 TUBECREAM14.184

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4245TOLNAFTATE CREAM [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 1 package rows20240701_63665de7-8415-651f-e053-2991aa0ac2bb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-0722-36GM - Gram0904-072226b64571-2bd2-4d74-afdc-5eae458205bb12013-08-02

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68071-424568071-4245-5
0904-0722

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETETH-20I835H2IHHXIACT
CHLOROCRESOL36W53O7109IACT
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSKH7I04HPUUIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
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
TolnaftateTOLNAFTATENuCare Pharmaceuticals,Inc.63665de7-8415-651f-e053-2991aa0ac2bb2024-06-06WarningsExact identifier
ndc (package): 68071-4245-5
ndc (product): 68071-4245
ndc11 (package): 68071424505
spl id: 1a3c5c49-b376-1318-e063-6394a90a47b6
spl set id: 63665de7-8415-651f-e053-2991aa0ac2bb

Reported adverse events (FAERS/openFDA)#

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