MICONAZOLE NITRATE

Manufacturer
ALLIED TRADE LINK LLC | GOPALDAS VISRAM AND COMPANY LMITED
Effective date
2024-11-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:37:00

Label at a glance#

ProductMICONAZOLE NITRATE
Active ingredientMICONAZOLE NITRATE
Label structure12 sections

Indications and uses

For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) Relieves itching, scaling, burning, discomfort and chafing associated with jock itch or itching, burning feet

Dosage and administration

Uses For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) Relieves itching, scaling, burning, discomfort and chafing associated with jock itch or itching, burning feet Clean the affected area and dry thoroughly Apply a thin layer of the cream over affected area twice daily (morning and night) or as directed by a doctor Supervise children in the use of this prod...

Label contents#

Full prescribing information#

Uses

OTC - ACTIVE INGREDIENT SECTION

For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) Relieves itching, scaling, burning, discomfort
and chafing associated with jock itch or itching, burning feet

Warnings For External Use Only

WARNINGS SECTION

Do not use On children under 2 years of age unless directed by a doctor For diaper rash.
When using this product Avoid contact with the eyes
Stop use and ask a doctor if Irritation occurs There is no improvement within 2 weeks when used for the treatment of jock itch There is no
improvement within 4 weeks when used for athlete's foot and ringworm
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do not use

OTC - DO NOT USE SECTION

Do not use On children under 2 years of age unless directed by a
doctor For diaper rash.

When using this product Avoid contact with the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if Irritation occurs There is no
improvement within 2 weeks when used for the treatment of jock

itch There is no improvement within 4 weeks when used for athlete's
foot and ringworm

Keep out of reach of children

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.

Other Information

OTHER SAFETY INFORMATION

Do not use if seal on the tube is damaged or
is not visible. To open, unscrew cap, pull tab to remove foil seal See
crimp of tube or carton for Lot Number and Expiry Date Preserve in
well-closed containers, and store controlled room temperature

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients Cetostearyl Alcohol, Chlorocresol, Edetate
Disodium, Light Mineral Oil, Macrogol Cetostearyl Ether, Propylene
Glycol, Purified Water, Sodium Phosphate Dibasic Dihydrate, Sodium
Phosphate Monobasic Dihydrate, White Petrolatum

Active Ingrediant

DOSAGE & ADMINISTRATION SECTION

Miconazole Nitrate 2%

WARNINGS FOR EXTERNAL USE ONLY

WARNINGS AND PRECAUTIONS SECTION

Miconazole Nitrate 2%

For External Use Only
Do not use On children under 2 years of age unless directed by a doctor For diaper rash.
When using this product Avoid contact with the eyes
Stop use and ask a doctor if Irritation occurs There is no improvement within 2 weeks when used for the treatment of jock itch There is no
improvement within 4 weeks when used for athlete's foot and ringworm
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS AND USES

INDICATIONS & USAGE SECTION

Uses
For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) Relieves itching, scaling, burning, discomfort
and chafing associated with jock itch or itching, burning feet

Clean the affected area and dry thoroughly Apply a thin layer of the cream 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 persists longer, consult a doctor This product is not effective on the scalp or nails

PURPOSDE

OTC - PURPOSE SECTION

Miconazole Nitrate 2% ........................................................................................................................................................................................................................................................................... Antifungal

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

miconazolemiconazole

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MICONAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84387-003-01MICONAZOLE NITRATE28.4 g in 1 TUBEOINTMENT28.42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84387-003MICONAZOLE NITRATE OINTMENT [ALLIED TRADE LINK LLC]2Current NDC, 1 package rows20241115_25520dba-0159-2a3f-e063-6294a90a4c33.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84387-00384387-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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 NITRATEMICONAZOLE NITRATEALLIED TRADE LINK LLC25520dba-0159-2a3f-e063-6294a90a4c332024-11-12WarningsExact identifier
ndc (package): 84387-003-01
ndc (product): 84387-003
ndc11 (package): 84387000301
spl id: 26bc78a5-3755-5f69-e063-6394a90a11a8
spl set id: 25520dba-0159-2a3f-e063-6294a90a4c33

Reported adverse events (FAERS/openFDA)#

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