Miconazole Nitrate 2%

Manufacturer
Pharmaceutica North America, Inc.
Effective date
2025-03-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:40:33

Label at a glance#

ProductMiconazole Nitrate 2%
Active ingredientMICONAZOLE NITRATE
Label structure8 sections

Indications and uses

• proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis) • relieves itching, scaling, cracking, burning and discomfort associated with 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 healthcare professional  Supervise children in the use of this product. For athlete's 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 leas...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2%

Purpose

OTC - PURPOSE SECTION

Anti-Fungal

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.
Do not use on 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 if

  • irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm) 
  • Irritation occurs, or if there is no improvement within 2 weeks (for jock itch).

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

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 healthcare professional 
  • Supervise children in the use of this product.

For athlete's 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 the scalp or nails.

Other information

SPL UNCLASSIFIED SECTION

• store at 15° - 30°C (59 - 86°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Carbomer, alcohol, cetostearyl alcohol, dimethyl sulfoxide, edetate disodium, ethylparaben, glycerol, mineral oil, mono and di glycerides, polyoxyethylene lauryl ether, purified water, stearic acid, triethanolamine, petrolatum.

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

image descriptionimage description

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45861-078MICONAZOLE NITRATE 2% (MICONAZOLE NITRATE) CREAM [PHARMACEUTICA NORTH AMERICA, INC.]1Unmatched20250316_ece786ea-a6ad-4aba-9108-bcfedcfafc14.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45861-078-03GM - Gram45861-078c4573348-e4b9-41e2-ace4-abe9436f54ea12025-05-14

Products#

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

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
45861-07845861-078-03

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
47e3ce6d-324a-96f3-e063-6294a90a209eece786ea-a6ad-4aba-9108-bcfedcfafc142026-01-08WarningsExact identifier
spl set id: ece786ea-a6ad-4aba-9108-bcfedcfafc14

Reported adverse events (FAERS/openFDA)#

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