Miconazole Nitrate Cream - Antifungal Cream

Manufacturer
Proficient Rx LP
Effective date
2021-04-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:47:45

Label at a glance#

ProductAntifungal
Active ingredientMICONAZOLE NITRATE
Label structure13 sections

Indications and uses

• proven clinically effective in the treatment of most athlete's foot, jock itch and ringworm • for effective relief of itching, scaling, cracking, burning and discomfort

Dosage and administration

• wash 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 wee...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole nitrate, USP 2%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • proven clinically effective in the treatment of most athlete's foot, jock itch and ringworm
  • for effective relief of itching, scaling, cracking, burning and discomfort

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

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

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot and 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.

 Directions

DOSAGE & ADMINISTRATION SECTION

  • wash 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
  • if condition lasts longer, contact a doctor
  • this product is not effective on the scalp or nails

Other information

SPL UNCLASSIFIED SECTION

  • store at controlled room temperature 59°-86°F (15°-30°C).
  • before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water

Questions?

OTC - QUESTIONS SECTION

 1-800-432-8534 between 9 am and 4 pm EST, Monday- Friday.

Distributed by: Actavis

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


NDC 63187-885-15
Compare to the active ingredient in Micatin® Antifungal Cream*  

Antifungal Cream
Miconazole Nitrate Cream, USP 2%
Soothes Itching, Scaling, Cracking, and Burning 

Cures Most Athlete’s Foot, Jock Itch & Ringworm 

Net wt. 0.5 oz (14g)

63187-885-15
63187-885-15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-885-15GM - Gram63187-885922efd71-0949-41a9-88f6-e83b37b3d01a12018-02-20
0472-0735-14GM - Gram0472-0735f296107a-ec2d-4ac6-856c-9be7c31a64f212013-02-13
0472-0735-42GM - Gram0472-073571184119-c239-45b1-bce9-4d7af04d60e012013-02-13
0472-0735-56GM - Gram0472-0735761b319f-8792-4e07-8364-da08d0cc556e12013-02-13

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63187-88563187-885-15
0472-0735

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML · Source PDF

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
333a5ecc-3693-40eb-8034-34133d81ad5f5e619dfa-4401-45bb-83c6-aaaa59203e5e2024-10-01WarningsExact identifier
spl set id: 5e619dfa-4401-45bb-83c6-aaaa59203e5e

Reported adverse events (FAERS/openFDA)#

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