FDA.reportPublic FDA data

Tolnaftate Antifungal Cream 1%

Manufacturer
REMEDYREPACK INC.
Effective date
2022-05-18
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:01:00

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 product avoid contact with eyes

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks

OTC - DO NOT USE SECTION

Do not use on 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

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

SPL UNCLASSIFIED SECTION

Distributed by: Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Tolnaftate Antifungal

GENERIC: Tolnaftate

DOSAGE: CREAM

ADMINSTRATION: TOPICAL

NDC: 70518-0142-0

COLOR: white

PACKAGING: 15 g in 1 TUBE

OUTER PACKAGING: 1 in 1 CARTON

ACTIVE INGREDIENT(S):

  • Tolnaftate 1g in 100g

INACTIVE INGREDIENT(S):

  • butylated hydroxytoluene
  • polyethylene glycol 400
  • polyethylene glycol 3350
  • titanium dioxide
  • petrolatum

Remedy_LabelRemedy_Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-0142-02020-04-01C16284748780-19d75b9d0-18af-f424-e053-dadaa90a57ceTolnaftate Antifungal Cream 1%
70518-0142-02020-01-31C16284748780-19d75b9d0-18af-f424-e053-dadaa90a57ceTolnaftate Antifungal Cream 1%

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-2020-1GM - Gram51672-20203065f191-8b9f-462a-aab4-d7476df3a57112013-02-13
51672-2020-2GM - Gram51672-2020a24f5108-1a7f-4f7a-b78f-586f6403fb3c12013-02-13

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
70518-014270518-0142-0
51672-2020

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tolnaftate AntifungalTOLNAFTATESun Pharmaceutical Industries, Inc.fa16fa08-fbbd-4f45-b64a-9bffe78e88612025-07-01WarningsExact identifier
ndc (product): 51672-2020
e4a35fc9-ae44-9314-e053-2a95a90a60ed87e9a04f-4724-4da4-85d1-3f2e0e03d1372022-07-25WarningsExact identifier
spl set id: 87e9a04f-4724-4da4-85d1-3f2e0e03d137

Reported adverse events (FAERS/openFDA)#

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