FDA.reportPublic FDA data

Miconazole Nitrate

Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2022-03-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:48:45

Label at a glance#

ProductMiconazole Nitrate
Active ingredientMICONAZOLE NITRATE
Label structure11 sections

Indications and uses

effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis) for effective relief of itching, scaling, burning and discomfort that can accompany these conditions.

Dosage and administration

clean the affected area and 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, and change shoes and socks at least once daily For athlete's foot and ringworm: use daily for 4 weeks. For jo...

Storage and handling

To open: unscrew cap, use pointed end on cap to puncture seal store at 20° - 25°C (68° - 77°F) see carton or tube crimp for lot number and expiration date

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole nitrate USP 2%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
  • for effective relief of itching, scaling, burning and discomfort that can accompany these conditions.

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on children less than 2 years of age unless directed by a doctor

OTC - WHEN USING SECTION

When using this product avoid contact with eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • condition persists
  • there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks.

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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean the affected area and 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, 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
  • not effective on the scalp or nails

Other information

STORAGE AND HANDLING SECTION

  • To open: unscrew cap, use pointed end on cap to puncture seal
  • store at 20° - 25°C (68° - 77°F)
  • see carton or tube crimp for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

apricot kernel oil, benzoic acid, BHT, glycol stearate, mineral oil, PEG-6, PEG-6-32 stearate, purified water

Questions?

OTC - QUESTIONS SECTION

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Distributed by:
Taro Pharmaceuticals
U.S.A., Inc.
Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL -

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2657-32025-01-30C16284748780-12cef2736-92b3-d83d-e063-dadaa90ab31fMiconazole Nitrate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2657-3Miconazole Nitrate1 in 1 CARTONCREAM11
68071-2657-3Miconazole Nitrate30 g in 1 TUBECREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2657MICONAZOLE NITRATE CREAM [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 2 package rows20220316_da4702fa-d3e9-7c71-e053-2995a90af334.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-2001-1GM - Gram51672-20019dbd7e37-8219-4939-b49c-0359e914af9712012-07-24
51672-2001-2GM - Gram51672-20019cf50338-1157-450f-91bd-7c055b0d494812013-02-13

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68071-265768071-2657-3
51672-2001

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
APRICOT KERNEL OIL54JB35T06AIACT
BENZOIC ACID8SKN0B0MIMIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
GLYCOL STEARATE0324G66D0EIACT
MINERAL OILT5L8T28FGPIACT
POLYETHYLENE GLYCOL 3005655G9Y8AQIACT
WATER059QF0KO0RIACT
PEG-6 STEARATE8LQC57C6B0IACT
PEG-32 STEARATE33GX5WQC0MIACT
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Miconazole NitrateMICONAZOLE NITRATESun Pharmaceutical Industries, Inc.7fd4037e-d350-47b7-a7d9-a43b8e366fa02026-08-25WarningsExact identifier
ndc (product): 51672-2001
da46fe67-ca70-8f0d-e053-2995a90a2c96da4702fa-d3e9-7c71-e053-2995a90af3342022-03-15WarningsExact identifier
spl id: da46fe67-ca70-8f0d-e053-2995a90a2c96
spl set id: da4702fa-d3e9-7c71-e053-2995a90af334

Reported adverse events (FAERS/openFDA)#

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