FDA.reportPublic FDA data

Tolnaftate Cream 1%

Manufacturer
Pharmacy Value Alliance, LLC. | Trifecta Pharmaceuticals USA, LLC.
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:47:24

Label at a glance#

ProductTolnaftate Cream 1%
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) Lot No & Expiration Date: See box or crimp of tube

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Anti-Fungal

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

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately.

Warnings

WARNINGS SECTION

For External Use Only

When using this product avoid contact with the eyes

Do not use on children under 2 years of age except under the advice and supervision of a doctor

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • there is no improvement within 4 weeks

Other Information

STORAGE AND HANDLING SECTION

  • Store between 20° to 25°C (68° to 77°F)
  • Lot No & Expiration Date: See box or crimp of tube

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Cetyl alcohol, Ethylparabe, Glycerol, Glyceryl Monostearate, Mineral Oil, Petrolatum, Purified Water, Sodium Dodecyl sulfate

Soothes Itching, Burning and Cracking

SPL UNCLASSIFIED SECTION

Distributed By:

Pharmacy Value Alliance, LLC.

407 East Lancaster Avenue, Wayne, PA. 19087 USA

www.emersongroup.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Anti-Fungal CreamAnti-Fungal Cream

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
68016-152-012023-05-09C16284748780-1ba0f9c33-55c1-a910-e053-dadaa90a0b85Tolnaftate Cream 1%
68016-152-012023-01-30C16284748780-1ba0f9c33-55c1-a910-e053-dadaa90a0b85Tolnaftate Cream 1%
68016-152-012021-08-10C16284748780-1ba0f9c33-55c1-a910-e053-dadaa90a0b85Tolnaftate Cream 1%
68016-152-012021-01-29C16284748780-1ba0f9c33-55c1-a910-e053-dadaa90a0b85Tolnaftate Cream 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-152-01Tolnaftate Cream 1%1 in 1 BOXCREAM15
68016-152-01Tolnaftate Cream 1%28 g in 1 TUBECREAM285

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-152TOLNAFTATE CREAM 1% (TOLNAFTATE) CREAM [PHARMACY VALUE ALLIANCE, LLC.]5Current NDC, Legacy NDC, 2 package rows20241222_3abfd734-229b-1a0e-e054-00144ff88e88.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-152-01EA - Each68016-15201999020-6fdb-4813-a13b-923a8c8acb5612022-06-06

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68016-15268016-152-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETOSTEARYL ALCOHOL2DMT128M1SIACT
STEARYL ALCOHOL2KR89I4H1YIACT
LIGHT MINERAL OILN6K5787QVPIACT
SODIUM LAURYL SULFATE368GB5141JIACT
WATER059QF0KO0RIACT
ETHYLPARABEN14255EXE39IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PETROLATUM4T6H12BN9UIACT
GLYCERINPDC6A3C0OXIACT
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 Cream 1%TOLNAFTATEPharmacy Value Alliance, LLC.3abfd734-229b-1a0e-e054-00144ff88e882024-12-20WarningsExact identifier
ndc (package): 68016-152-01
ndc (product): 68016-152
ndc11 (package): 68016015201
spl id: 29b74830-546d-c90b-e063-6294a90a4e72
spl set id: 3abfd734-229b-1a0e-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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