FDA.reportPublic FDA data

Miconazole Nitrate

Manufacturer
AvKARE
Effective date
2026-01-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:33:46

Label at a glance#

ProductMiconazole Nitrate
Active ingredientMICONAZOLE NITRATE
Label structure9 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 thin layer of powder over affected area twice daily (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 athletes foot and ringworm, use daily for 4 weeks for jock itch, ...

Storage and handling

protect from freezing. Avoid excessive heat. do not use if package is damaged

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2.0%

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 - DO NOT USE SECTION

  • on children under 2 years of age unless 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, dicontinue use and consult a doctor

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean the affected area and dry thoroughly
  • apply a thin layer of powder over affected area twice daily (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 athletes 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

STORAGE AND HANDLING 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

PRINCIPAL DISPLAY PANEL - 85 g Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

xx

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998461miconazole nitrate 2 % Topical PowderPSN2
998461miconazole nitrate 0.02 MG/MG Topical PowderSCD2
998461miconazole nitrate 2 % Topical PowderSY2

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
42291-938-85Miconazole Nitrate85 g in 1 BOTTLEPOWDER852

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-938-85GM - Gram42291-938262c4b1b-dab1-42ea-a5bb-6c7a0067a55012024-07-12

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42291-93842291-938-85
69367-399

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
ALLANTOIN344S277G0ZIACT
CHLOROXYLENOL0F32U78V2QIACT
IMIDUREAM629807ATLIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
TRICALCIUM PHOSPHATEK4C08XP666IACT
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 NitrateMICONAZOLE NITRATEAvKARE1a26534d-eeb8-8d17-e063-6294a90a70c72026-01-19WarningsExact identifier
ndc (package): 42291-938-85
ndc (product): 42291-938
ndc11 (package): 42291093885
spl id: 48c0e508-e6c0-3d43-e063-6294a90a3ade
spl set id: 1a26534d-eeb8-8d17-e063-6294a90a70c7

Reported adverse events (FAERS/openFDA)#

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