FDA.reportPublic FDA data

Micotrin AP

Manufacturer
PureTek Corporation
Effective date
2024-10-01
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:22:35

Label at a glance#

ProductMicotrin AP
Active ingredientMICONAZOLE NITRATE
Label structure8 sections

Indications and uses

for the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) relieves itching, burning, cracking, scaling and discomfort which accompany 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 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 joc...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2.0%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • for the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
  • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.

WARNINGS SECTION

For external use only.

Do not use on

SPL UNCLASSIFIED SECTION

children under 2 years of age unless directed by a doctor

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • for athlete's foot and ringworm - irritation occurs or there is no improvement within 4 weeks
  • for jock itch - irritation occurs or there is no improvement within 2 weeks

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

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 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.

Other information

OTHER SAFETY INFORMATION

■ protect from freezing ■ avoid excessive heat ■ do not use if package is damaged

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aleurites Moluccana (Kukui) Seed Oil, Aloe Barbadensis (Aloe Vera) Leaf Juice Powder, Bisabolol, Carthamus Tinctorius (Safflower) Oleosomes, Fragrance, Nylon-12, Silica, Sodium Benzoate, Sodium Hyaluronate, Zea Mays (Corn) Starch, Zingiber Officinale (Ginger) Root Extract.

Micotrin AP™

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

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
59088-478-07Micotrin AP85 g in 1 BOTTLEPOWDER855

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-478MICOTRIN AP (MICONAZOLE NITRATE) POWDER [PURETEK CORPORATION]5Current NDC, Legacy NDC, 1 package rows20241004_cbe3d495-cdee-2343-e053-2a95a90a5b82.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-478-07GM - Gram59088-478b0bfef2f-6f1e-476f-9f9c-b64173ddd43612021-11-09

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59088-47859088-478-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
LEVOMENOL24WE03BX2TIACT
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES9S60Q72309IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM BENZOATEOJ245FE5EUIACT
MICONAZOLE NITRATEVW4H1CYW1KACTIB
HYALURONATE SODIUMYSE9PPT4THIACT
STARCH, CORNO8232NY3SJIACT
GINGERC5529G5JPQIACT
ALOE VERA LEAFZY81Z83H0XIACT
NYLON-12446U8J075BIACT
KUKUI NUT OILTP11QR7B8RIACT

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
Micotrin APMICONAZOLE NITRATEPureTek Corporationcbe3d495-cdee-2343-e053-2a95a90a5b822024-10-01WarningsExact identifier
ndc (package): 59088-478-07
ndc (product): 59088-478
ndc11 (package): 59088047807
spl id: 23737640-ab36-eddf-e063-6394a90a3bef
spl set id: cbe3d495-cdee-2343-e053-2a95a90a5b82

Reported adverse events (FAERS/openFDA)#

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