MICONAZOLE Nitrate 2% Cream ANTIFUNGAL

Manufacturer
RTMH Enterprises DBA Research Technology Medical Home
Effective date
2022-12-28
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:52:40

Label at a glance#

ProductMICONAZOLE Nitrate 2% Cream ANTIFUNGAL
Active ingredientMICONAZOLE NITRATE
Label structure10 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 shoe...

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

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fugeon Box labelFugeon Box label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998483miconazole nitrate 2 % Topical CreamPSN5
998483miconazole nitrate 20 MG/ML Topical CreamSCD5
998483miconazole nitrate 2 % Topical CreamSY5

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72071-101-212024-01-30C16284748780-11030e365-110d-111a-e063-dadaa90a10e2MICONAZOLE Nitrate 2% Cream ANTIFUNGAL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72071-101-21MICONAZOLE Nitrate 2% Cream ANTIFUNGAL15 g in 1 TUBECREAM155
72071-101-21MICONAZOLE Nitrate 2% Cream ANTIFUNGAL1 in 1 BOXCREAM15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72071-101MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [RTMH ENTERPRISES DBA RESEARCH TECHNOLOGY MEDICAL HOME]5Legacy NDC, 2 package rows20221229_76ee5b72-9ca3-5030-e053-2a91aa0a475f.zip

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
72071-10172071-101-21

Ingredients#

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

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

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
f0e79299-054d-af9d-e053-2a95a90a39d076ee5b72-9ca3-5030-e053-2a91aa0a475f2022-12-28WarningsExact identifier
spl id: f0e79299-054d-af9d-e053-2a95a90a39d0
spl set id: 76ee5b72-9ca3-5030-e053-2a91aa0a475f

Reported adverse events (FAERS/openFDA)#

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