TM -Tolnaftate

Manufacturer
Singular Dreamer, Ltd dba True Marker
Effective date
2024-10-22
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 20:51:31

Label at a glance#

ProductTM -Tolnaftate
Active ingredientTOLNAFTATE
Label structure9 sections

Indications and uses

Proven clinically effective in the treatment of most fungal infections including related/associated to tinea pedis (athlete’s foot), tinea cruris (jock itch) and tinea corporis (ringworm) For effective relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort associated to fungal infections Prevents most tinea pedis (athlete’s foot) with daily use.

Dosage and administration

clean the affected area and dry thoroughly apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily Supervise children in the use of this product For athlete’s foot: pay special attention to spaces between the toes; wear well-fi...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Topical Antifungal

Uses

INDICATIONS & USAGE SECTION

  • Proven clinically effective in the treatment of most fungal infections including related/associated to tinea pedis (athlete’s foot), tinea cruris (jock itch) and tinea corporis (ringworm)
  • For effective relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort associated to fungal infections
  • Prevents most tinea pedis (athlete’s foot) with daily use.

Warnings

WARNINGS SECTION

  • For external use only
  • Do Not Use– On children under 2 years of age unless directed by a doctor.
  • When using this product, avoid contact with eyes.
  • Stop use and ask a doctor, if irritation occurs of if there is no improvement within 4 weeks, discontinue use and consult a doctor (within 2 weeks for jock itch)
  • Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.
  • If pregnant or breast-feeding, ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean the affected area and dry thoroughly
  • apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
  • Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
  • 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
  • For athlete’s foot and ringworm, use daily for 4 weeks
  • If condition persists longer, consult a doctor
  • This product is not effective on the scalp or nails.

Other information

SPL UNCLASSIFIED SECTION

Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Helianthus Annuus (Sunflower) Oil, Vitis Vinifera (Grape) Seed Oil, Mentha Piperita (Peppermint) Oil, Tocopheryl Acetate (Vitamin E), BHT (Butylated hydroxytoluene)

Questions?

SPL UNCLASSIFIED SECTION

304-742-2433

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83035-1260-3ML - Milliliter83035-1260b5c3618a-fa9b-44f0-a2c2-ab43bd1839cb12023-05-05
83035-1260-4ML - Milliliter83035-1260a5a40656-e069-4ad5-96c3-e110f6c29c5612023-09-05

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83035-126083035-1260-3, 83035-1260-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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
2516fb44-38b8-8bd3-e063-6394a90a5593964ff52d-fd2a-47b4-bdc5-6a3ef2fc40bc2024-10-22WarningsExact identifier
spl id: 2516fb44-38b8-8bd3-e063-6394a90a5593
spl set id: 964ff52d-fd2a-47b4-bdc5-6a3ef2fc40bc

Reported adverse events (FAERS/openFDA)#

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