FDA.reportPublic FDA data

Miconazole Nitrate Cream 2%

Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2023-04-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:54:44

Label at a glance#

ProductMiconazole Nitrate Cream 2%
Active ingredientMICONAZOLE NITRATE
Label structure10 sections

Indications and uses

• For the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) • Relieves itching, scaling, burning, discomfort and chafing associated with jock itch or itching, burning feet

Dosage and administration

• Clean the affected area and dry thoroughly. Apply a thin layer of cream 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 • Fo...

Storage and handling

• Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal • Store at room temperature • See crimp of tube or carton for Lot Number and Expiry Date

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 treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
• Relieves itching, scaling, burning, discomfort and chafing associated with jock itch or itching, burning feet

Warnings

WARNINGS SECTION

For external use only

Do not use • on children under 2 years of age unless directed by a doctor • for diaper rash

When using this product • avoid contact with the eyes

Stop use and ask a doctor if • irritation occurs • there is no improvement within 2 weeks when used for the treatment of jock itch • there is no improvement within 4 weeks when used for athlete’s foot or ringworm

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 cream 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 condition persists longer, consult a doctor. • This product is not effective on the scalp or nails

Other information

STORAGE AND HANDLING SECTION

• Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal • Store at room temperature • See crimp of tube or carton for Lot Number and Expiry Date

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Cetostearyl Alcohol, Chlorocresol, Edetate Disodium, Light Mineral Oil, Macrogol Cetostearyl Ether, Propylene Glycol, Purified Water, Sodium Phosphate Dibasic Dihydrate, Sodium Phosphate Monobasic Dihydrate, White Petrolatum

Questions or comments?

OTC - QUESTIONS SECTION

718-502-6610 between 9 am to 4 pm EST, Monday-Friday.

SPL UNCLASSIFIED SECTION

Cures Most Athlete's Foot

Compared to the active ingredient in Micatin ®*

Relieves Itching and Burning Sensation Relieves from Cracking and scaling. Grease less and non-staining

*This product is not affiliated with, manufactured by, or produced by the makers or owners of Micatin ®

Distributed by:

EzriCare, LLC

Lakewood, NJ

www.EzriCare.com

Made in India

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998483miconazole nitrate 2 % Topical CreamPSN1
998483miconazole nitrate 20 MG/ML Topical CreamSCD1
998483miconazole nitrate 2 % Topical CreamSY1

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
68071-2978-32025-01-30C16284748780-12cef2736-b446-d83d-e063-dadaa90ab31fEZRI CARE TM Miconazole Nitrate Cream USP 2%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2978-3Miconazole Nitrate Cream 2%1 in 1 CARTONCREAM11
68071-2978-3Miconazole Nitrate Cream 2%30 g in 1 TUBECREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2978MICONAZOLE NITRATE CREAM 2% (MICONAZOLE NITRATE) CREAM [NUCARE PHARMACEUTICALS,INC.]12 package rows20230418_f990672c-d959-38f2-e053-6394a90a8025.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
79503-106-30GM - Gram79503-1066bf6d148-fb76-4c54-ba53-678c126dd76312022-05-04

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68071-297868071-2978-3
79503-106

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CHLOROCRESOL36W53O7109IACT
EDETATE DISODIUM7FLD91C86KIACT
LIGHT MINERAL OILN6K5787QVPIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE94255I6E2TIACT
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956IACT
WHITE PETROLATUMB6E5W8RQJ4IACT
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
f9905f4e-1b1d-c7e7-e053-6294a90a9545f990672c-d959-38f2-e053-6394a90a80252023-04-17WarningsExact identifier
spl id: f9905f4e-1b1d-c7e7-e053-6294a90a9545
spl set id: f990672c-d959-38f2-e053-6394a90a8025

Reported adverse events (FAERS/openFDA)#

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