FDA.reportPublic FDA data

TM-Tolnaftate LR

Manufacturer
Singular Dreamer Ltd.dba True Marker
Effective date
2024-10-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:51:36

Label at a glance#

ProductTM-Tolnaftate LR
Active ingredientTOLNAFTATE
Label structure8 sections

Indications and uses

for the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis). relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.  for the prevention of most Athlete's foot with daily use eliminates fungus on fingers, toes and around the nails.  eliminates and helps stop the spread of fungal infections on cuticles around nail edges and under the nail tips where rea...

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) paying special attention to the edges of the nail, cuticles and skin around the nails 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 ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • for the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis).
  • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions. 
  • for the prevention of most Athlete's foot with daily use eliminates fungus on fingers, toes and around the nails. 
  • eliminates and helps stop the spread of fungal infections on cuticles around nail edges and under the nail tips where reachable with applicator brush.

Warnings

WARNINGS SECTION

• For external use only
• Do Not Use– On children under 2 years of age 
• When using this product, do not get into eyes
• Stop use and ask a doctor

  • for athlete's foot and ringworm - if irritation occurs or there is no improvement within 4 weeks
  • for prevention of athlete's foot - if irritation occurs, discontinue use and consult a doctor 
  • for athlete's foot and ringworm - if irritation occurs or there is no improvement within 4 weeks 
  • for prevention of athlete's foot - if irritation occurs, discontinue use and consult a doctor

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) paying special attention to the edges of the nail, cuticles and skin around the nails 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 for athlete's foot and ringworm, use daily for 4 weeks 
  • if condition persists longer, consult a doctor.

Other information

SPL UNCLASSIFIED SECTION

  • Store at 15 - 30°C (59 - 86°F) 
  • avoid excessive heat 
  • do not use if package is damaged

Inactive ingredients

INACTIVE INGREDIENT SECTION

a-Bisabalol, Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetearyl Alcohol, Curcuma Longa (Turmeric) Extract, Dimethyl Isosorbide, Ethylhexylglycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Hydroxyethyl Acrylate/Sodium AcryloyldimethylTaurate Copolymer, Isohexadecane, Isopropyl Alcohol, Melaleuca Alternifolia (Tea Tree) Oil, Phenoxyethanol, Polysorbate
60, Sodium Hydroxide, Thymus Vulgaris (Thyme) Extract, Zingiber Officinalis (Ginger) Extract.

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
83035-1262-4ML - Milliliter83035-1262ab8c7dd6-51d2-4ea2-b007-abf7552aaffe12023-07-06

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83035-126283035-1262-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
BISABOLOL OXIDE A16AE65F94YIACT
ALLANTOIN344S277G0ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
TURMERIC856YO1Z64FIACT
DIMETHYL ISOSORBIDESA6A6V432SIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
ISOHEXADECANE918X1OUF1EIACT
ISOPROPYL ALCOHOLND2M416302IACT
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 60CAL22UVI4MIACT
SODIUM HYDROXIDE55X04QC32IIACT
THYMECW657OBU4NIACT
GINGERC5529G5JPQIACT
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
2516f704-3577-61e7-e063-6394a90a7041d67267eb-45b5-438f-b16c-9e1ee52303602024-10-22WarningsExact identifier
spl id: 2516f704-3577-61e7-e063-6394a90a7041
spl set id: d67267eb-45b5-438f-b16c-9e1ee5230360

Reported adverse events (FAERS/openFDA)#

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