FDA.reportPublic FDA data

Miconazole Nitrate

Manufacturer
McKesson | Central Solutions
Effective date
2024-10-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:24:16

Label at a glance#

ProductMiconazole Nitrate
Active ingredientMICONAZOLE NITRATE
Label structure11 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Miconazole Nitrate 2%

OTC - PURPOSE SECTION

Purpose

Antifungal

INDICATIONS & USAGE SECTION

Uses

Treats most jock itch, ringworm and athlete’s foot

WARNINGS SECTION

Warnings

Do not use

  • on children under 2 years of age
  • for diaper rash.

For external use only.

Avoid contact with eyes.

OTC - STOP USE SECTION

Consult a Doctor

If irritation occurs or if there is no improvement within 4 weeks for athlete’s foot or ringworm,

or within 2 weeks for jock itch.

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • 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 physician.
  • Supervise children in the use of this product.

Athlete’s foot

  • Pay special attention to the spaces between toes
  • wear well-fitting, ventilated shoes and change shoes and socks at least once daily

Athlete’s foot and ringworm

  • use daily for 4 weeks

Jock Itch

  • use daily for 2 weeks.

If condition persists longer, consult a doctor.

OTHER SAFETY INFORMATION

Other Information

  • This product is not effective on scalp or nails.
  • Store at 59-86ºF (15-30ºC).

INACTIVE INGREDIENT SECTION

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, BHT, Cetyl Alcohol, Dimethicone,
DMDM Hydantoin, Glycerin, Glyceryl Stearate, Isopropyl Palmitate, PEG 100 Stearate,Iodopropynyl Butylcarbamate,

Propylene Glycol, Purified Water, Stearic Acid, Triethanolamine (may contain Citric Acid).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68599-1471-4

McKesson
Antifungal Cream 2%
MICONAZOLE
NITRATE

Relieves itching, cracking, scaling and
discomfort associated with most jock itch,
ringworm and athlete’s foot.

4 fl oz
(118.3 mL)

MFR # 53-6391

53-639153-6391

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998483miconazole nitrate 2 % Topical CreamPSN3
998483miconazole nitrate 20 MG/ML Topical CreamSCD3
998483miconazole nitrate 2 % Topical CreamSY3

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
68599-1471-42021-09-15C16284748780-1ba0f9c33-3bd0-a910-e053-dadaa90a0b85Antifungal
68599-1471-42021-01-29C16284748780-1ba0f9c33-3bd0-a910-e053-dadaa90a0b85Antifungal

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68599-1471-4Miconazole Nitrate118 mg in 1 TUBECREAM1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68599-1471MICONAZOLE NITRATE (ANTIFUNGAL) CREAM [MCKESSON]3Current NDC, Legacy NDC, 1 package rows20241012_8dcca44a-16c7-7262-e053-2a95a90a1b23.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68599-147168599-1471-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
DMDM HYDANTOINBYR0546TOWIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
PEG-100 STEARATEYD01N1999RIACT
STEARIC ACID4ELV7Z65APIACT
ALOE VERA LEAFZY81Z83H0XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
TROLAMINE9O3K93S3TKIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
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 NitrateANTIFUNGALMcKesson8dcca44a-16c7-7262-e053-2a95a90a1b232024-10-10WarningsExact identifier
ndc (package): 68599-1471-4
ndc (product): 68599-1471
ndc11 (package): 68599147104
spl id: 2424691e-9201-a1b8-e063-6294a90a1cde
spl set id: 8dcca44a-16c7-7262-e053-2a95a90a1b23

Reported adverse events (FAERS/openFDA)#

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