MICONAZOLE NITRATE

Manufacturer
DirectRx
Effective date
2022-04-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:04:05

Label at a glance#

ProductMICONAZOLE NITRATE
Active ingredientMICONAZOLE NITRATE
Label structure11 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Miconazole nitrate USP, 2%

OTC - PURPOSE SECTION

Antifungal

OTC - WHEN USING 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 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
there is no improvement within 4 weeks (for athlete's foot and ringworm) or 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) right away.

OTHER SAFETY INFORMATION

do not use if foil seal on tube opening is broken or missing
to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use
store at room temperature 15°-30°C (59°-86°F)
before using any medication, read all label directions. Keep carton, it contains important information.

INDICATIONS & USAGE SECTION

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

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

SPL UNCLASSIFIED SECTION

Distributed by: H2-Pharma, LLC
Montgomery, AL 36117

WARNINGS AND PRECAUTIONS 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 the 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-345-28GM - Gram72189-34593e715c0-e065-43bf-8135-c0898672636612022-05-04
61269-735-14GM - Gram61269-735d8f29709-852e-47b8-aa8b-855bed7d7ff512021-07-15
61269-735-42GM - Gram61269-7350120fd90-5843-41fa-beea-8e0b2780984112021-07-15
61269-735-56GM - Gram61269-73547f4642f-3ed7-47e4-933e-190f35e5bbf512021-07-15

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
72189-34572189-345-28
61269-735

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
07d9b739-ead1-d06a-e063-6294a90a7413dc11c03e-3451-c4c0-e053-2a95a90a0d692023-10-16WarningsExact identifier
spl set id: dc11c03e-3451-c4c0-e053-2a95a90a0d69

Reported adverse events (FAERS/openFDA)#

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