FDA.reportPublic FDA data

Miconazole Nitrate

Manufacturer
Topco Associates LLC
Effective date
2016-01-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:45:35

Label at a glance#

ProductMiconazole Nitrate
Active ingredientMICONAZOLE NITRATE
Label structure9 sections

Indications and uses

for the cure of most athlete's foot, jock itch and ringworm

Dosage and administration

clean the affected area and dry thoroughly apply a thin layer of product 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 the 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 i...

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 cure of most athlete's foot, jock itch and ringworm

Warnings

WARNINGS SECTION

For External use only.

Do not use

OTC - DO NOT USE SECTION

on children under 2 years of age unless directed by a doctor.

when using this product

OTC - WHEN USING SECTION

avoid contact with the eyes

Stop and ask a doctor if

OTC - STOP USE SECTION

irritation occurs or there is no improvement within 4 weeks for athlete's foot and ringworm, or 2 weeks for jock itch.

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 thin layer of product 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 the 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 conditions persist longer, consult a doctor
  • this product is not effective on the scalp or nails

Other Information

OTHER SAFETY INFORMATION

  • store between 59º - 86ºF
  • lightly shake bottle to loosen settled powder

Inactive ingredients

INACTIVE INGREDIENT SECTION

aldioxa, chloroxylenol, fragrance, imidurea, powdered cellulose, talc

Questions?

OTC - QUESTIONS SECTION

Call 1-888-423-0139

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare

ANTIFUNGAL POWDER

MiconasorbAF

Miconazole Nitrate 2%

  • Cures and soothees most athlete's foot, jock itch & ringworm
  • Relieves chafing, itching, burning & scaling
  • Absorbs moisture

COMPARE TO ZEASORB active ingredients

NET WT 2.5 OZ (71g)

Topcare Miconazorb AF Powder LABEL.jpgTopcare Miconazorb AF Powder LABEL.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998461miconazole nitrate 2 % Topical PowderPSN1
998461miconazole nitrate 0.02 MG/MG Topical PowderSCD1
998461miconazole nitrate 2 % Topical PowderSY1

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
36800-071-252021-07-23C16284748780-19d75b9cf-d0d9-f424-e053-dadaa90a57ceAnti - Fungal Powder
36800-071-252021-02-22C16284748780-19d75b9cf-d0d9-f424-e053-dadaa90a57ceAnti - Fungal Powder
36800-071-252020-01-31C16284748780-19d75b9cf-d0d9-f424-e053-dadaa90a57ceAnti - Fungal Powder

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-071-25Miconazole Nitrate71 g in 1 BOTTLE, PLASTICPOWDER711

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-071MICONAZOLE NITRATE (ANTI-FUNGAL POWDER MICONAZOLE NITRATE) POWDER [TOPCO ASSOCIATES LLC]1Legacy NDC, 1 package rows20160401_7ac90517-7d9b-4d94-b1c9-b424ad907a59.zip

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
36800-07136800-071-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICONAZOLE NITRATEVW4H1CYW1KACTIB
ALDIOXA8T66I31YNKIACT
CHLOROXYLENOL0F32U78V2QIACT
IMIDUREAM629807ATLIACT
POWDERED CELLULOSESMD1X3XO9MIACT
TALC7SEV7J4R1UIACT

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
9e12cded-f09c-46a8-a617-49dfeab2d02a7ac90517-7d9b-4d94-b1c9-b424ad907a592016-01-20WarningsExact identifier
spl id: 9e12cded-f09c-46a8-a617-49dfeab2d02a
spl set id: 7ac90517-7d9b-4d94-b1c9-b424ad907a59

Reported adverse events (FAERS/openFDA)#

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