FDA.reportPublic FDA data

Tolnaftate

Manufacturer
Sheffield Pharmaceuticals LLC
Effective date
2025-02-20
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:55:45

Label at a glance#

ProductTolnaftate
Active ingredientTOLNAFTATE
Label structure12 sections

Indications and uses

Cures most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis). Relieves the  itching, irratation, redness, scaling and discomfort which can accompany these conditions.

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 Pay special attention to the spaces between the toes. Wear well fitting ventilated shoes. Change shoes and socks at least once daily. For athlete's foot and ringworm, use daily for 4 weeks. ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate USP 1%

Purpose

OTC - PURPOSE SECTION

Antifungal Cream

Uses

INDICATIONS & USAGE SECTION

  • Cures most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis).
  • Relieves the  itching, irratation, redness, scaling and discomfort which can accompany these conditions.

Warnings

WARNINGS SECTION

  • Do not use on children under 2 years of age unless directed by a doctor.
  • For external use only avoid contact with eyes.
  • 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).

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

  • Pay special attention to the spaces between the toes.
  • Wear well fitting ventilated shoes.
  • Change shoes and socks at least once daily.
  • For athlete's foot and ringworm, use daily for 4 weeks.
  • 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).
  • Close cap tighty after ever use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

1-800-222-1087

Principal Display Panel – 1.25 oz Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dr. Sheffield's NDC 11527-051-40

1% Tolnafate

Antifungal Cream

CURES Most:

ATHLETE'S FOOT

JOCK ITCH

RINGWORM

Net Wt. 1.25 OZ (35.4 g)

Sheffield Antifungal 1.25oz TubeSheffield Antifungal 1.25oz Tube

Principal Display Panel – 1.25 oz Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dr. Sheffield's NDC 11527-051-40

1%  Tolnafate

Antifungal Cream 

CURES Most:

ATHLETE'S FOOT

JOCK ITCH

RINGWORM 

Net Wt. 1.25 OZ (35.4 g)

Sheffield Antifungal 1.25 CartonSheffield Antifungal 1.25 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11527-051-40Tolnaftate1 in 1 CARTONCREAM15
11527-051-40Tolnaftate35.4 g in 1 TUBECREAM35.45
11527-051-51Tolnaftate1 in 1 CARTONCREAM15
11527-051-51Tolnaftate14 g in 1 TUBECREAM145

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11527-051TOLNAFTATE CREAM [SHEFFIELD PHARMACEUTICALS LLC]5Current NDC, Legacy NDC, 4 package rows20250223_ca52af37-c3a2-414c-a24a-a37a92925133.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11527-051-40GM - Gram11527-051fb4787af-9168-47e7-a878-1188c3b9e8b412021-06-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TOLNAFTATEACTIVE INGREDIENT06KB629TKV1
TOLNAFTATEACTIVE MOIETY06KB629TKV1
CETETH-20INACTIVE INGREDIENTI835H2IHHX1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S1
CHLOROCRESOLINACTIVE INGREDIENT36W53O71091
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSINACTIVE INGREDIENTKH7I04HPUU1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
11527-05111527-051-40, 11527-051-51

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
TOLNAFTATE06KB629TKVACTIB
WATER059QF0KO0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETETH-20I835H2IHHXIACT
CHLOROCRESOL36W53O7109IACT
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSKH7I04HPUUIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

Source Document#

Source XML

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 · 21 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CHLOROCRESOLCHLOROCRESOL36W53O7109CREAM / TOPICAL5 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CETETH-20CETETH-20I835H2IHHXCREAM / TOPICAL429 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CETETH-20CETETH-20I835H2IHHXCREAM / TOPICAL429 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSSODIUM PHOSPHATE, MONOBASIC, ANHYDROUSKH7I04HPUUCREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CHLOROCRESOLCHLOROCRESOL36W53O7109CREAM / TOPICAL5 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSSODIUM PHOSPHATE, MONOBASIC, ANHYDROUSKH7I04HPUUCREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSSODIUM PHOSPHATE, MONOBASIC, ANHYDROUSKH7I04HPUUCREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CETETH-20CETETH-20I835H2IHHXCREAM / TOPICAL429 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CHLOROCRESOLCHLOROCRESOL36W53O7109CREAM / TOPICAL5 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
3 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
TolnaftateTOLNAFTATESheffield Pharmaceuticals LLCca52af37-c3a2-414c-a24a-a37a929251332025-02-20WarningsExact identifier
ndc (package): 11527-051-40
ndc (package): 11527-051-51
ndc (product): 11527-051
ndc11 (package): 11527005140
ndc11 (package): 11527005151
spl id: b4271182-7791-423e-8335-dfd5cb5d859b
spl set id: ca52af37-c3a2-414c-a24a-a37a92925133

Reported adverse events (FAERS/openFDA)#

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