MICONAZOLE Nitrate 2% Cream ANTIFUNGAL

Manufacturer
GERI-GENTLE CORPORATION
Effective date
2025-04-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:59:29

Label at a glance#

ProductMICONAZOLE Nitrate 2% Cream ANTIFUNGAL
Active ingredientMICONAZOLE NITRATE
Label structure12 sections

Indications and uses

For the treatment and prevention 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)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2% w/w

Purpose

OTC - PURPOSE SECTION

Anti-Fungal

Uses

INDICATIONS & USAGE SECTION

  • For the treatment and prevention 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

OTC - DO NOT USE SECTION

on children under 2 years of age unless directed by Doctor

When using this product

OTC - WHEN USING SECTION

Avoid contact with eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation occurs

there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch)

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion contact a physician or Poison Control Center right away and discomfort which accompany these conditions

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.

Other Information

STORAGE AND HANDLING SECTION

• Store at 15° - 30° c (59° - 86° f)

INACTIVE INGREDIENT SECTION

Caprylic/capric triglyceride, Cetereath-20, Cetearyl Alcohol, Chlorocresol, Dimethicone, Disodium EDTA, Glyceryl Stearate, Imidazolidinyl Urea, PEG-100 Stearate, PEG-40 Castor Oil, Petrolatum, Propylene Glycol, Sodium Cetearyl Sulfate, Stearic Acid, Water, Xanthum Gum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display and Drug Fact PanelPrincipal Display and Drug Fact Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998483miconazole nitrate 2 % Topical CreamPSN2
998483miconazole nitrate 20 MG/ML Topical CreamSCD2
998483miconazole nitrate 2 % Topical CreamSY2

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
69771-041-252025-04-21C16284748780-11030e365-30f7-111a-e063-dadaa90a10e2MICONAZOLE Nitrate 2% Cream ANTIFUNGAL
69771-041-252024-01-30C16284748780-11030e365-30f7-111a-e063-dadaa90a10e2MICONAZOLE Nitrate 2% Cream ANTIFUNGAL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69771-041-25MICONAZOLE Nitrate 2% Cream ANTIFUNGAL113 g in 1 TUBECREAM1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69771-041MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [GERI-GENTLE CORPORATION]2Current NDC, Legacy NDC, 1 package rows20250423_e6734616-c16b-430c-e053-2a95a90a18f8.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69771-04169771-041-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATEGERI-GENTLE CORPORATIONe6734616-c16b-430c-e053-2a95a90a18f82025-04-21WarningsExact identifier
ndc (package): 69771-041-25
ndc (product): 69771-041
ndc11 (package): 69771004125
spl id: 334ee902-e3c8-59f1-e063-6294a90adee6
spl set id: e6734616-c16b-430c-e053-2a95a90a18f8

Reported adverse events (FAERS/openFDA)#

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