FDA.reportPublic FDA data

Miconazole Nitrate

Manufacturer
LEADER/ Cardinal Health 110, Inc.
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:48:00

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 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. Do not use on children under 2 years of age unless directed by a doctor.

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

allantoin, chloroxylenol, fragrance, imidazolidinyl urea, microcrystalline cellulose, tricalicum phosphate, zea mays (corn) starch

Questions?

OTC - QUESTIONS SECTION

call 1-866-964-0939

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER

Moisture Absorbing

Antifungal Powder

Miconzole Nitrate 2% | Antfungal

Cures Most Athlete's Foot, Jock Itch, and Ringworm

Relieves Chafing, Itching, Burning, and Scaling

Absorbs Moisture

Talc - Free

2.5 OZ (71 g)

Leader_Antifungal Miconazorb Powder Talc-Free_50-081LD_51-081LD.jpgLeader_Antifungal Miconazorb Powder Talc-Free_50-081LD_51-081LD.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998461miconazole nitrate 2 % Topical PowderPSN9
998461miconazole nitrate 0.02 MG/MG Topical PowderSCD9
998461miconazole nitrate 2 % Topical PowderSY9

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
70000-0323-1Miconazole Nitrate71 g in 1 BOTTLE, WITH APPLICATORPOWDER719

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0323MICONAZOLE NITRATE (ANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREE) POWDER [LEADER/ CARDINAL HEALTH 110, INC.]9Legacy NDC, 1 package rows20241222_e754d590-0a92-4605-89a3-e698b8906672.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0323-1GM - Gram70000-0323a3b9e495-fa7c-435e-aa75-a1aefc4f9d9712018-03-08

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
70000-032370000-0323-1

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
ZEA MAYS SUBSP. MAYS WHOLE1G5HNE09V8IACT
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
29bae1bd-515b-ee2a-e063-6294a90a27a4e754d590-0a92-4605-89a3-e698b89066722024-12-20WarningsExact identifier
spl id: 29bae1bd-515b-ee2a-e063-6294a90a27a4
spl set id: e754d590-0a92-4605-89a3-e698b8906672

Reported adverse events (FAERS/openFDA)#

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