FDA.reportPublic FDA data

MICONAZOLE Nitrate 2% Cream ANTIFUNGAL - Trifecta Pharmaceuticals Usa Llc

Manufacturer
Trifecta Pharmaceuticals Usa Llc
Effective date
2026-03-31
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
full-release
Hydrated at
2026-06-01 01:52:20

Label at a glance#

ProductMICONAZOLE Nitrate 2% Cream ANTIFUNGAL
Active ingredientMICONAZOLE NITRATE
Label structure11 sections

Indications and uses

proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea crurus), and ringworm (tinea capitis) relieves itching, scaling, cracking, burning and discomfort associated with these conditions.

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 healthcare professional • Supervise children in the use of this product. For athlete's foot:  • Use daily for 4 weeks. If condition persists, consult a healthcare professional. • Pay special attention to the spaces between the toes • Wear well fitting, ventilated sho...

Storage and handling

• Store at 15° - 30° c (59° - 86° f) • Lot number and expiration date see crimp of tube or see box. • To open: Unscrew cap, tear safety seal off. You may report serious side effects to: QC@trifecta-pharma.com

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2%

Purpose

OTC - PURPOSE SECTION

Anti-Fungal

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 immediately.

Uses

INDICATIONS & USAGE SECTION

  • proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea crurus), and ringworm (tinea capitis)
  • relieves itching, scaling, cracking, burning and discomfort associated with these conditions.

Warnings

WARNINGS SECTION

For external use only. Do not use if the safety-sealed tube is punctured or damaged.

Do not use on children under 2 years of age unless directed by a healthcare professional. When using this product avoid contact with the eyes.

Stop use and ask a healthcare professional if • irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm) • Irritation occurs, or if there is no improvement within 2 weeks (for jock itch).

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 healthcare professional • Supervise children in the use of this product.

For athlete's foot: • Use daily for 4 weeks. If condition persists, consult a healthcare professional. • Pay special attention to the spaces between the toes • Wear well fitting, ventilated shoes • Change socks atleast once daily.

For ringworm: Use daily for 4 weeks. If condition persists, consult a healthcare professional.

For jock itch: Use daily for 2 weeks. If condition persists longer, consult a healthcare professional.

This product is not effective on the scalp or nails.

INACTIVE INGREDIENT SECTION

Inactive ingredients Carbomer, cetostearyl alcohol, dimethyl sulfoxide, edetate disodium, ethylparaben, glycerol, glyceryl distearate, mineral oil, peregal-o, purified water, stearic acid, triethanolamine, petrolatum.

Other Information

STORAGE AND HANDLING SECTION

• Store at 15° - 30° c (59° - 86° f) • Lot number and expiration date see crimp of tube or see box. • To open: Unscrew cap, tear safety seal off.

You may report serious side effects to: QC@trifecta-pharma.com

SPL UNCLASSIFIED SECTION

FAST RELIEF 100% GUARANTEED

Relieves Itching and Burning

Also Cures Athlete's Foot and Ringworm

Distributed by:
Trifecta Pharmaceuticals USA TM
101 NE Third Avenue Suite 1500
Ft. Lauderdale, FL 33301 USA
www.trifecta-pharma.com

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

77012-FBA GLOBE MICONAZOLE NITRATE CREAM 1OZ 3PK_BOX 061224 CDER77012-FBA GLOBE MICONAZOLE NITRATE CREAM 1OZ 3PK_BOX 061224 CDER

LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4022 GLOBE MICONAZOLE NITRATE CREAM 1OZ UPC 022224 CDER4022 GLOBE MICONAZOLE NITRATE CREAM 1OZ UPC 022224 CDER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998483miconazole nitrate 2 % Topical CreamPSN14
998483miconazole nitrate 20 MG/ML Topical CreamSCD14
998483miconazole nitrate 2 % Topical CreamSY14

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130040232381461GTIN-13: 0040232381461
EAN-13: 0040232381461
GTIN-12: 040232381461
UPC-A: 040232381461
GTIN storage (14 digits): 00040232381461		4022 GLOBE MICONAZOLE NITRATE CREAM 1OZ UPC 022224 CDER.jpg
Data codeCode 128X0049S2VVL77012-FBA GLOBE MICONAZOLE NITRATE CREAM 1OZ 3PK_BOX 061224 CDER.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-014-04MICONAZOLE Nitrate 2% Cream ANTIFUNGAL118.3 g in 1 TUBECREAM118.314
69396-014-05MICONAZOLE Nitrate 2% Cream ANTIFUNGAL15 g in 1 TUBECREAM1514
69396-014-20MICONAZOLE Nitrate 2% Cream ANTIFUNGAL1 in 1 BOXCREAM114
69396-014-20MICONAZOLE Nitrate 2% Cream ANTIFUNGAL30 g in 1 TUBECREAM3014
69396-014-33MICONAZOLE Nitrate 2% Cream ANTIFUNGAL3 in 1 BOXCREAM314
69396-014-33MICONAZOLE Nitrate 2% Cream ANTIFUNGAL30 g in 1 TUBECREAM3014
69396-014-44MICONAZOLE Nitrate 2% Cream ANTIFUNGAL30 g in 1 TUBECREAM3014
69396-014-44MICONAZOLE Nitrate 2% Cream ANTIFUNGAL4 in 1 BOXCREAM414
69396-014-66MICONAZOLE Nitrate 2% Cream ANTIFUNGAL6 in 1 BOXCREAM614
69396-014-66MICONAZOLE Nitrate 2% Cream ANTIFUNGAL30 g in 1 TUBECREAM3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69396-014-05GM - Gram69396-01467a4d687-f389-41b0-90b6-be0807a7d1e612024-01-04
69396-014-20GM - Gram69396-0146d9d1334-578d-493a-b171-4ffa9ada0f5f12018-06-11

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69396-01469396-014-20, 69396-014-05, 69396-014-04, 69396-014-44, 69396-014-33, 69396-014-66

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICONAZOLE NITRATEVW4H1CYW1KACTIB
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DIMETHYL SULFOXIDEYOW8V9698HIACT
EDETATE DISODIUM7FLD91C86KIACT
ETHYLPARABEN14255EXE39IACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL DISTEARATE73071MW2KMIACT
MINERAL OILT5L8T28FGPIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
WATER059QF0KO0RIACT
STEARIC ACID4ELV7Z65APIACT
TROLAMINE9O3K93S3TKIACT
PETROLATUM4T6H12BN9UIACT

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
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATETrifecta Pharmaceuticals Usa Llc80217dbb-a0f0-414a-8d22-a9a346b017aa2026-03-31WarningsExact identifier
ndc (package): 69396-014-33
ndc (package): 69396-014-05
ndc (package): 69396-014-20
ndc (package): 69396-014-44
ndc (package): 69396-014-66
ndc (package): 69396-014-04
ndc (product): 69396-014
ndc11 (package): 69396001466
ndc11 (package): 69396001444
ndc11 (package): 69396001404
ndc11 (package): 69396001405
ndc11 (package): 69396001420
ndc11 (package): 69396001433
spl id: 4e55e0bf-9e9d-d877-e063-6294a90a9d59
spl set id: 80217dbb-a0f0-414a-8d22-a9a346b017aa

Reported adverse events (FAERS/openFDA)#

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