FDA.reportPublic FDA data

Miconazole Nitrate Antifungal Powder

Manufacturer
Marlex Pharmaceuticals, Inc.
Effective date
2025-11-21
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:17:38

Label at a glance#

ProductMiconazole Nitrate Antifungal Powder
Active ingredientMICONAZOLE NITRATE
Label structure10 sections

Indications and uses

For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) For the treatment of most superficial skin infections caused by yeast (candida albicans) Relieves most itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch

Dosage and administration

Clean the affected area and dry thoroughly Apply a layer of power over affected area twice a day (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 dai...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
  • For the treatment of most superficial skin infections caused by yeast (candida albicans)
  • Relieves most itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch

Warnings

WARNINGS SECTION

  • For external use only

Do not use

OTC - STOP USE SECTION

  • on children under 2 years of age unless directed by a doctor
  • avoid contact with the eyes
  • for athlete's foot and ringworm- if irritation occurs, or if there is no improvement within 4 weeks, discontinue use and consult a doctor
  • for jock itch - if irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a doctor

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean the affected area and dry thoroughly
  • Apply a layer of power over affected area twice a day (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.

Other Information

SPL UNCLASSIFIED SECTION

  • Protect from freezing. Avoid excessive heat.
  • Do not use if package is damaged

Inactive ingredients

INACTIVE INGREDIENT SECTION

Allantoin, Chloroxylenol, fragrance, Imidazolidinyl Urea, Microcrystalline Cellulose, Tricalcium Phosphate, Corn starch.

Manufactured For/ Distributed By:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev. 04/22 DV

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998461miconazole nitrate 2 % Topical PowderPSN4
998461miconazole nitrate 0.02 MG/MG Topical PowderSCD4
998461miconazole nitrate 2 % Topical PowderSY4

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-720-85Miconazole Nitrate Antifungal Powder85 g in 1 BOTTLEPOWDER854

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-720-85GM - Gram10135-720c77ed009-d3ea-4b1d-ac86-b4a628c5e62212022-06-06

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10135-72010135-720-85

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHLOROXYLENOL0F32U78V2QIACT
IMIDUREAM629807ATLIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
TRICALCIUM PHOSPHATEK4C08XP666IACT
ALLANTOIN344S277G0ZIACT
STARCH, CORNO8232NY3SJIACT
MICONAZOLE NITRATEVW4H1CYW1KACTIB

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 Antifungal PowderMICONAZOLE NITRATE ANTIFUNGAL POWDERMarlex Pharmaceuticals, Inc.de4f703c-39e9-855e-e053-2a95a90a6ea92025-11-21WarningsExact identifier
ndc (package): 10135-720-85
ndc (product): 10135-720
ndc11 (package): 10135072085
spl id: 441cab8b-3a58-00e0-e063-6294a90aaa23
spl set id: de4f703c-39e9-855e-e053-2a95a90a6ea9

Reported adverse events (FAERS/openFDA)#

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