FDA.reportPublic FDA data

TriTolnacide C

Manufacturer
Trifluent Pharma LLC
Effective date
2025-10-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:38:53

Label at a glance#

ProductTriTolnacide C
Active ingredientTOLNAFTATE
Label structure10 sections

Indications and uses

Cures most Athlete's Foot (Tinea Pedis), Jock Itch (Tinea Cruris), and Ringworm (Tinea Corporis) Relieves itching, cracking, burning, and scaling, which accompany these conditions Clinically proven to prevent most Athlete's Foot (Tinea Pedis) with daily use Clears up most Athlete's Foot (Tinea Pedis) infection and with daily use helps keep it from coming back

Dosage and administration

Wash the affected area with soap and water and dry thoroughly Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a physician 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 dai...

Storage and handling

Store at room temperature 20-28°C (68 - 82°F); do not store in extreme heat

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

  • Cures most Athlete's Foot (Tinea Pedis), Jock Itch (Tinea Cruris), and Ringworm (Tinea Corporis)
  • Relieves itching, cracking, burning, and scaling, which accompany these conditions
  • Clinically proven to prevent most Athlete's Foot (Tinea Pedis) with daily use
  • Clears up most Athlete's Foot (Tinea Pedis) infection and with daily use helps keep it from coming back

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on children under 2 years of age unless directed by a physician

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a physician or pharmacist before use if you are using any other medicines or cleansers on your skin

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes: rinse immediately with cool tap water if contact occurs
  • Do not use for vaginal yeast

OTC - STOP USE SECTION

Stop use and ask a physician if irritation occurs or if there is no improvement within 4 weeks (for Athlete's Foot or Ringworm) or within 2 weeks (for Jock Itch)

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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wash the affected area with soap and water and dry thoroughly
  • Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a physician
  • 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. For Jock Itch, use daily for 2 weeks. If condition persists longer, consult a physician
  • This product is not effective on the scalp or nails
  • To prevent Athlete's Foot, wash the feet and dry thoroughly; apply a thin layer of the product to the feet once or twice daily (morning and/or night)
  • Wash hands after each use

Other information

STORAGE AND HANDLING SECTION

Store at room temperature 20-28°C (68 - 82°F); do not store in extreme heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alkyl (C12-15) Benzoate, Butylparaben, Carica Papaya (Papaya) Fruit Extract, Carthamus Tinctorius (Safflower) Seed Oil, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Dimethicone, Emulsifying Wax, Ethylparaben, Glycerin, Glycerol Stearate, Hydrogenated Polydecene, Isobutylparaben, Melaleuca Alternifolia (Tea Tree) Oil, Methylparaben, PEG 100 Stearate, Phenoxyethanol, Polyethylene Glycol 400, Propylene Glycol, Propylparaben, Purfied Water, Sodium Polyacrylate, Trideceth-6, Xanthan Gum

Questions/Comments?

OTC - QUESTIONS SECTION

(210) 944-6920

PRINCIPAL DISPLAY PANEL - 37 mL Pouch Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tear at notch to open. Do not use if seal is broken.

PRODUCT SHOULD BE ADMINISTERED UNDER THE
SUPERVISION OF A LICENSED MEDICAL PRACTITIONER

TRIFLUENT
PHARMA™

TriTolnacide™ C

TOLNAFTATE

ANTIFUNGAL CREAM
NDC 73352-561-10

1.25 FL. OZ. (37 mL)

PRINCIPAL DISPLAY PANEL - 37 mL Pouch Tube Label
PRINCIPAL DISPLAY PANEL - 37 mL Pouch Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
103951tolnaftate 1 % Topical CreamPSN4
2685262TriTolnacide C 1 % Topical CreamPSN4
2685262tolnaftate 10 MG/ML Topical Cream [Tritolnacide]SBD4
103951tolnaftate 10 MG/ML Topical CreamSCD4
103951tolnaftate 1 % Topical CreamSY4
2685262Tritolnacide 1 % Topical CreamSY4
2685262Tritolnacide 10 MG/ML Topical CreamSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73352-561-10TriTolnacide C37 mL in 1 BOTTLE, WITH APPLICATORCREAM374
73352-561-10TriTolnacide C1 in 1 POUCHCREAM14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73352-561-10ML - Milliliter73352-561b028f486-18bb-4901-8e33-76f36053d16b12024-09-09

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73352-56173352-561-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
TOLNAFTATE06KB629TKVACTIB
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
BUTYLPARABEN3QPI1U3FV8IACT
PAPAYAKU94FIY6JBIACT
SAFFLOWER OIL65UEH262ISIACT
CETYL ALCOHOL936JST6JCNIACT
CHAMOMILEFGL3685T2XIACT
DIMETHICONE, UNSPECIFIED92RU3N3Y1OIACT
ETHYLPARABEN14255EXE39IACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HYDROGENATED POLYDECENE TYPE IU333RI6EB7IACT
ISOBUTYLPARABEN0QQJ25X58GIACT
TEA TREE OILVIF565UC2GIACT
METHYLPARABENA2I8C7HI9TIACT
PEG-100 MONOSTEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
TRIDECETH-63T5PCR2H0CIACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32024-11-20full-release2026-06-01 00:38:13

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
TriTolnacide CTOLNAFTATETrifluent Pharma LLC12b53c2a-b073-43db-88d9-ede8300626aa2025-10-14WarningsExact identifier
ndc (package): 73352-561-10
ndc (product): 73352-561
ndc11 (package): 73352056110
spl id: 93f89016-a625-43cc-9537-6b2411e5ef7e
spl set id: 12b53c2a-b073-43db-88d9-ede8300626aa

Reported adverse events (FAERS/openFDA)#

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