LEADER ANTIFUNGAL TOLNAFTATE

Manufacturer
REMEDYREPACK INC.
Effective date
2017-10-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:11:07

Label at a glance#

ProductLEADER ANTIFUNGAL TOLNAFTATE
Active ingredientTOLNAFTATE
Label structure12 sections

Storage and handling

Other Information store between 20 o to 25 o C (68 o to 77 o F) Lot No. & Exp. Date: see box or see crimp of tube

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient                                                     Purpose

Tolnaftate 1%.........................................................Antifungal

OTC - PURPOSE SECTION

Uses

  • proven clinically effective in the treatment of athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
  • proven effective in the prevention of athlete's foot with daily use
  • for effectively relief of itching, burning and cracking

WARNINGS SECTION

Warnings

For external use only

OTC - WHEN USING SECTION

When using this product avoid contact with the 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.

INDICATIONS & USAGE SECTION

Directions

  • Wash affected area and dry thoroughly
  • Apply a thin layer over 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 spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once daily
  • use daily for 4 week; if condition persists longer, ask a doctor
  • this product is not effective on the scalp or nails

STORAGE AND HANDLING SECTION

Other Information

  • store between 20 o to 25 oC (68 o to 77 oF)
  • Lot No. & Exp. Date: see box or see crimp of tube

INACTIVE INGREDIENT SECTION

Inactive Ingredients

butylated hydroxytoluene, cetanol, liquid paraffin, methylparaben, prolyoxyethylene cetyl ether, propylene glycol, propylparaben, purified water, sorbitan monostearate, stearyl alcohol

DOSAGE & ADMINISTRATION SECTION

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

Made in Korea

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: LEADER ANTIFUNGAL TOLNAFTATE

GENERIC: TOLNAFTATE

DOSAGE: CREAM

ADMINSTRATION: TOPICAL

NDC: 70518-0794-0

PACKAGING: 28 g in 1 TUBE

ACTIVE INGREDIENT(S):

  • TOLNAFTATE 10mg in 1g

INACTIVE INGREDIENT(S):

  • BUTYLATED HYDROXYTOLUENE
  • WATER
  • PROPYLPARABEN
  • SORBITAN MONOSTEARATE
  • PROPYLENE GLYCOL
  • CETYL ALCOHOL
  • METHYLPARABEN
  • PARAFFIN
  • STEARYL ALCOHOL

Remedy_LabelRemedy_Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-0794-02020-05-04C16284748780-19d75b9d0-0949-f424-e053-dadaa90a57ce90106b13-e001-403a-a3ee-9629c1a7e1c8
70518-0794-02020-01-31C16284748780-19d75b9d0-0949-f424-e053-dadaa90a57ce90106b13-e001-403a-a3ee-9629c1a7e1c8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37205-197-10GM - Gram37205-1974a172659-0fbd-427e-a0ca-e39a3cc8e92212013-02-13

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
70518-079470518-0794-0
37205-197

Ingredients#

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

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

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
a4d7b504-0dc5-7d9f-e053-2a95a90a1bef90106b13-e001-403a-a3ee-9629c1a7e1c82020-05-04WarningsExact identifier
spl set id: 90106b13-e001-403a-a3ee-9629c1a7e1c8

Reported adverse events (FAERS/openFDA)#

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