FDA.reportPublic FDA data

Globe Clotrimazole (Topical Solution) USP 1%

Manufacturer
Trifecta Pharmaceuticals USA, LLC.
Effective date
2024-02-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:08:51

Label at a glance#

ProductClotrimazole Antifungal
Active ingredientCLOTRIMAZOLE
Label structure14 sections

Indications and uses

Cures most Athlete's foot (tinea pedis) Jock Itch (Tinea Cruris) Ringwork (Tinea corporis) Effectively relieves Itching Cracking Burning Discomfort that can accompany these conditions

Dosage and administration

Spray over affected area If bandaged, let dry first Not to be used on children under 12 years of age

Storage and handling

Store at controlled room temperature 15º-30ºC (59º-86ºF)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole USP, 1.0%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

Cures most

  • Athlete's foot (tinea pedis)
  • Jock Itch (Tinea Cruris)
  • Ringwork (Tinea corporis)

Effectively relieves

  • Itching
  • Cracking
  • Burning

Discomfort that can accompany these conditions

Warnings

WARNINGS SECTION

For External Use Only

Stop use and ask a doctor

OTC - STOP USE SECTION

  • If irritation occurs
  • If there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)

Ask a Doctor before use

OTC - ASK DOCTOR SECTION

Ask a doctor before use on children under 2 years of age

When using this product

OTC - WHEN USING SECTION

Avoid Contact with Eyes.

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately

Directions

DOSAGE & ADMINISTRATION SECTION

  • Spray over affected area
  • If bandaged, let dry first
  • Not to be used on children under 12 years of age

Other information

STORAGE AND HANDLING SECTION

  • Store at controlled room temperature 15º-30ºC (59º-86ºF)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Ethanol, Propylene glycol, purified water

Questions or Comments

OTC - QUESTIONS SECTION

Call 1-888-296-9067

Distributed By:

SPL UNCLASSIFIED SECTION

Trifecta Pharmaceuticals USA®

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

Globe® Clotrimazole anti-fungal solution is not manufactured or distributed by Bayer, owner of the registered trademark Lotrimin®AF.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4310 GLOBE CLOTRIMAZOLE SOLUTION 1 percent 10ML 110723 CDER FILE4310 GLOBE CLOTRIMAZOLE SOLUTION 1 percent 10ML 110723 CDER FILE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309370clotrimazole 1 % Topical SolutionPSN1
309370clotrimazole 10 MG/ML Topical SolutionSCD1
309370clotrimazole 1 % Topical SolutionSY1

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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-143-33Clotrimazole Antifungal1 in 1 BOXSOLUTION11
69396-143-33Clotrimazole Antifungal0.01 L in 1 BOTTLESOLUTION0.011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-143CLOTRIMAZOLE ANTIFUNGAL (CLOTRIMAZOLE) SOLUTION [TRIFECTA PHARMACEUTICALS USA, LLC.]1Current NDC, 2 package rows20240223_11bf50db-552e-0a39-e063-6394a90af60d.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69396-14369396-143-33

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
CLOTRIMAZOLEG07GZ97H65ACTIB
ALCOHOL3K9958V90MIACT

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
Clotrimazole AntifungalCLOTRIMAZOLETrifecta Pharmaceuticals USA, LLC.11bf50db-552e-0a39-e063-6394a90af60d2024-02-19WarningsExact identifier
ndc (package): 69396-143-33
ndc (product): 69396-143
ndc11 (package): 69396014333
spl id: 11bf503d-be71-0b75-e063-6394a90aa94e
spl set id: 11bf50db-552e-0a39-e063-6394a90af60d

Reported adverse events (FAERS/openFDA)#

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