MICONAZOLE Nitrate 2% Cream ANTIFUNGAL

Manufacturer
Cardinal Health 110 dba LEADER | Trifecta Pharmaceuticals USA LLC
Effective date
2025-05-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:00:56

Label at a glance#

ProductMICONAZOLE Nitrate 2% Cream ANTIFUNGAL
Active ingredientMICONAZOLE NITRATE
Label structure10 sections

Indications and uses

proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea crurus), and ringworm (tinea capitis) relieves itching, scaling, cracking, burning and discomfort associated with these conditions.

Dosage and administration

Directions: Clean the affected area and dry thoroughly Apply a thin layer of the product over the affected area twice daily, morning and night or as directed by a doctor. Supervise children in the use of this product For Athletes Foot U se daily for 4 weeks. If condition persists, consult a doctor Pay special Attention to the spaces between the toes Wear well fitting, ventilated shoes Change socks at least once da...

Storage and handling

• Store at 15° - 30° c (59° - 86° f) • Lot number and expiration date see crimp of tube or see box. • To open: Unscrew cap, tear safety seal off.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2%

Purpose

OTC - PURPOSE SECTION

Anti-Fungal

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 (1-800-222-1222) immediately.

Uses

INDICATIONS & USAGE SECTION

  • proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea crurus), and ringworm (tinea capitis)
  • relieves itching, scaling, cracking, burning and discomfort associated with these conditions.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions: Clean the affected area and dry thoroughly

  • Apply a thin layer of the product over the affected area twice daily, morning and night or as directed by a doctor.
  • Supervise children in the use of this product

For Athletes Foot

  • Use daily for 4 weeks. If condition persists, consult a doctor
  • Pay special Attention to the spaces between the toes
  • Wear well fitting, ventilated shoes
  • Change socks at least once daily

For Ringworm

  • Use daily for 4 weeks. If condition persists, consult a doctor

For Jock Itch

  • Use Daily for 2 weeks. If condition persists longer, consult a doctor.

This product is not effective on scalp and nails

​

Warnings

WARNINGS SECTION

For external use only. Do not use if the safety-sealed tube is punctured or damaged.

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

When using this product avoid contact with the eyes.

Stop use and ask a doctor • irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm)

If irritation occurs or if there is no improvement within 2 weeks (for Jock Itch).

INACTIVE INGREDIENT SECTION

Inactive ingredients: Alcohol, Carbomer, cetostearyl alcohol, dimethyl sulfoxide, edetate disodium, ethylparaben, glycerol, Mineral Oil, Mono and di glycerides, Petrolatum, Polyoxyethylene lauryl ether, purified water, stearic acid, triethanolamine.

Other Information

STORAGE AND HANDLING SECTION

• Store at 15° - 30° c (59° - 86° f) • Lot number and expiration date see crimp of tube or see box. • To open: Unscrew cap, tear safety seal off.

SPL UNCLASSIFIED SECTION

Distributed by:
Cardinal Health TM
Dublin, Ohio 43017

www.myleader.com

1-800-200-6313

Essential to Care ™ since 1979

©2024 Cardinal Health. All rights reserved. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the LEADER LOGO, are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.

All Leader Brand Products have a 100% money back guarantee.

Return to place of purchase of not satisfied.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5950951 LEADER MICONAZOLE NITRATE CREAM 1OZ 041625 CDER5950951 LEADER MICONAZOLE NITRATE CREAM 1OZ 041625 CDER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998483miconazole nitrate 2 % Topical CreamPSN2
998483miconazole nitrate 20 MG/ML Topical CreamSCD2
998483miconazole nitrate 2 % Topical CreamSY2

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
70000-0718-1MICONAZOLE Nitrate 2% Cream ANTIFUNGAL1 in 1 BOXCREAM12
70000-0718-1MICONAZOLE Nitrate 2% Cream ANTIFUNGAL28 g in 1 TUBECREAM282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0718MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [CARDINAL HEALTH 110 DBA LEADER]2Current NDC, 2 package rows20250515_34f4c733-2eb2-0db0-e063-6394a90a6431.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0718-1GM - Gram70000-07185a05a5a3-8b58-4b7e-876c-a06c605325c412026-04-20

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-071870000-0718-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

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 Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATECardinal Health 110 dba LEADER34f4c733-2eb2-0db0-e063-6394a90a64312025-05-13WarningsExact identifier
ndc (package): 70000-0718-1
ndc (product): 70000-0718
ndc11 (package): 70000071801
spl id: 3504ed0b-c60f-7b38-e063-6294a90ad91d
spl set id: 34f4c733-2eb2-0db0-e063-6394a90a6431

Reported adverse events (FAERS/openFDA)#

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