FDA.reportPublic FDA data

Trimazole

Manufacturer
Trifluent Pharma LLC
Effective date
2025-12-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:18:55

Label at a glance#

ProductTrimazole
Active ingredientCLOTRIMAZOLE
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.

Dosage and administration

Wash the affected area with soap and water and dry thoroughly. Apply a thin layer of the product over the 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 toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily. For Athlete's Foot and Ringworm, use da...

Storage and handling

Store at 15-30°C (59-86°F). Avoid excessive heat. Do not use if product is damaged.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole 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.

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 doctor

OTC - ASK DOCTOR SECTION

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

OTC - WHEN USING SECTION

When using this product avoid contact with eyes; rinse immediately with cool tap water if contact occurs.

OTC - STOP USE SECTION

Stop use and ask a doctor 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 - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

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) immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wash the affected area with soap and water and dry thoroughly.
  • Apply a thin layer of the product over the 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 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 doctor.
  • This product is not effective on the scalp or nails.
  • Wash hands after each use.

Other information

STORAGE AND HANDLING SECTION

Store at 15-30°C (59-86°F). Avoid excessive heat.

Do not use if product is damaged.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe barbadensis leaf extract, aminomethyl propanol, caprylic / capric triglyceride, cetyl alcohol, disodium EDTA, glyceryl stearate, hydroxypropylcellulose, Lavandula angustifolia (lavender) oil, Melaleuca alternifolia (tea tree) oil, methylparaben, PEG 100 stearate, polyethylene glycol 400, polysorbate 20, polysorbate 60, propylene glycol, propylparaben, purified water, stearic acid.

Questions/Comments?

OTC - QUESTIONS SECTION

(210) 944-6920

PRINCIPAL DISPLAY PANEL - 85 G Tube Pouch Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

NDC 73352-570-01

TRIFLUENT
PHARMA™

Trimazole™

1% Clotrimazole

Topical Antifungal Cream

NET WT. 3 OZ. (85 G)

PRINCIPAL DISPLAY PANEL - 85 G Tube Pouch Label
PRINCIPAL DISPLAY PANEL - 85 G Tube Pouch Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309367clotrimazole 1 % Topical CreamPSN2
2685228Trimazole 1 % Topical CreamPSN2
2685228clotrimazole 10 MG/ML Topical Cream [Trimazole]SBD2
309367clotrimazole 10 MG/ML Topical CreamSCD2
309367clotrimazole 1 % Topical CreamSY2
2685228Trimazole 1 % Topical CreamSY2
2685228Trimazole 10 MG/ML Topical CreamSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CLOTRIMAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73352-570-01Trimazole1 in 1 POUCHCREAM12
73352-570-01Trimazole85 g in 1 TUBECREAM852

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73352-570-01GM - Gram73352-57000cf7ea7-6b17-4627-9ef5-e43a37f1abd512024-09-09

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
73352-57073352-570-01

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
CLOTRIMAZOLEG07GZ97H65ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETYL ALCOHOL936JST6JCNIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
LAVENDER OILZBP1YXW0H8IACT
TEA TREE OILVIF565UC2GIACT
METHYLPARABENA2I8C7HI9TIACT
PEG-100 MONOSTEARATEYD01N1999RIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POLYSORBATE 207T1F30V5YHIACT
POLYSORBATE 60CAL22UVI4MIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
STEARIC ACID4ELV7Z65APIACT

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
TrimazoleCLOTRIMAZOLETrifluent Pharma LLCa3bafc52-1404-4e0b-84c1-e28bffcb091e2025-12-01WarningsExact identifier
ndc (package): 73352-570-01
ndc (product): 73352-570
ndc11 (package): 73352057001
spl id: 58684c1e-44b9-4525-be6a-8492da88ec45
spl set id: a3bafc52-1404-4e0b-84c1-e28bffcb091e

Reported adverse events (FAERS/openFDA)#

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