FDA.reportPublic FDA data

Miconazole Nitrate

Manufacturer
Hudson Health LLC
Effective date
2025-10-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:39:57

Label at a glance#

ProductMiconazole Nitrate
Active ingredientMICONAZOLE NITRATE
Label structure10 sections

Indications and uses

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

Dosage and administration

clean the affected area & dry thoroughly apply a thin layer of the 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, & change shoes & socks at least once daily for athlete's foot & ringworm, use daily for 4 weeks; for jock itch,...

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean the affected area & dry thoroughly
  • apply a thin layer of the 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, & change shoes & socks at least once daily
  • for athlete's foot & 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

ZEA MAYS (CORN) STARCH, TRICALICUM PHOSPHATE, MICROCRYSTALLINE CELLULOSE, SODIUM BICARBONATE, ALLANTOIN, CHLOROXYLENOL, FRAGRANCE

Questions?

OTC - QUESTIONS SECTION

Call 1-866-964-0939

RECENT MAJOR CHANGES SECTION

.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

comfortzone

miconazorbAF

antifungal powder

micronazole nitrate 2% /

antifungal

  • cures most athlete's foot,

jock itch & ringworm

  • relieves chafing, itching,

burning & scaling

  • absorbs moisture
  • comforts & refreshes
  • talc-free

NET WT. 2.5 OZ. (71g)

cartoncartoncartoncarton

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeCode 128(01)10034197017258GTIN-14: 10034197017258
GTIN storage (14 digits): 10034197017258		Amazon_Miconazorb AF Powder_Talc Free_51-081AM-B03.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72446-014-01Miconazole Nitrate71 g in 1 BOTTLE, PLASTICPOWDER712

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
72446-01472446-014-01

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
SODIUM BICARBONATE8MDF5V39QOIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
TRICALCIUM PHOSPHATEK4C08XP666IACT
ZEA MAYS (CORN) STARCHO8232NY3SJIACT
MICONAZOLE NITRATEVW4H1CYW1KACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-06-05full-release2026-06-01 01:02:28

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 NitrateANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREEHudson Health LLC36ec5f05-5d1c-25df-e063-6394a90a9dd92025-10-24WarningsExact identifier
ndc (package): 72446-014-01
ndc (product): 72446-014
ndc11 (package): 72446001401
spl id: 41eec725-8a57-1cd8-e063-6294a90a9221
spl set id: 36ec5f05-5d1c-25df-e063-6394a90a9dd9

Reported adverse events (FAERS/openFDA)#

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