Miconatate

Manufacturer
PureTek Corporation
Effective date
2024-10-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:26:25

Label at a glance#

ProductMiconatate
Active ingredientTOLNAFTATE, MICONAZOLE NITRATE
Label structure24 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%

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

WARNINGS SECTION

For external use only.

Do not use on

OTC - DO NOT USE 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

OTC - KEEP OUT OF REACH OF CHILDREN 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

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

SPL UNCLASSIFIED 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.

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • for the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis).
  • relieves itching, burning, cracking, scaling, and discomfort which accompany these conditions.
  • for the prevention of most Athlete’s foot with daily use.
  • eliminates fungus on fingers, toes, and around the nails.
  • eliminates and helps stop the spread of fungal infections on cuticles around nail edges and under the nail tips where reachable with applicator brush.

Warnings

WARNINGS SECTION

For external use only

Do not use on

OTC - DO NOT USE 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

OTC - STOP USE SECTION

  • for athlete's foot and ringworm - if irritation occurs or there is no improvement within 4 weeks
  • for prevention of athlete’s foot - if irritation occurs, discontinue use and consult a doctor

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) paying special attention to the edges of the nail, cuticles, and skin around the nails 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
  • if condition persists longer, consult a doctor.

Use under the direction of a medical practitioner

Other information

SPL UNCLASSIFIED SECTION

  • Store at 15 - 30°C (59° - 86°F) [see USP Controlled Room Temperature].
  • avoid excessive heat
  • do not use if package is damaged

How Supplied

HOW SUPPLIED SECTION

Mycozyl AL™ Antifungal Liquid is supplied in a 1 fl oz / 30 mL glass bottle with a screw cap fitted with a brush applicator (NDC 59088-443-03)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Apple Cider Vinegar, Argania Spinosa (Argan) Kernel Oil, Benzyl Alcohol, DMSO (Dimethyl Sulfoxide), Eucalyptus Globulus (Eucalyptus) Leaf Oil, Glycerin, Laureth-4, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, PEG-8, DL-alpha-tocopheryl acetate.

Miconatate™

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Packaged in the USA by:
PureTek Corporation
Panorama City, CA 91402
For questions or information
call toll-free: 877-921-7873

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998461miconazole nitrate 2 % Topical PowderPSN3
313423tolnaftate 1 % Topical SolutionPSN3
998461miconazole nitrate 0.02 MG/MG Topical PowderSCD3
313423tolnaftate 10 MG/ML Topical SolutionSCD3
998461miconazole nitrate 2 % Topical PowderSY3
313423tolnaftate 1 % Topical SolutionSY3

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
59088-442-07Miconatate85 g in 1 BOTTLEPOWDER1 g in 852 g in 85g3
59088-443-03Miconatate30 mL in 1 BOTTLE, WITH APPLICATORLIQUID1 mL in 300.3 g in 30mL3
59088-778-00Miconatate1 in 1 CARTONKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-442MICONATATE (MICONAZOLE NITRATE AND TOLNAFTATE) KIT [PURETEK CORPORATION]3Current NDC, Legacy NDC20241018_c45c8f8f-9042-a428-e053-2a95a90acda9.zip
59088-443MICONATATE (MICONAZOLE NITRATE AND TOLNAFTATE) KIT [PURETEK CORPORATION]3Current NDC, Legacy NDC20241018_c45c8f8f-9042-a428-e053-2a95a90acda9.zip
59088-778MICONATATE (MICONAZOLE NITRATE AND TOLNAFTATE) KIT [PURETEK CORPORATION]3Current NDC, Legacy NDC, 3 package rows20241018_c45c8f8f-9042-a428-e053-2a95a90acda9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-778-00EA - Each59088-778b3a7207e-e755-4651-939b-5dbbfdfb700412021-10-08
59088-443-03ML - Milliliter59088-443958250a3-49e2-439f-998a-bf21bf22ea5212021-08-05
59088-442-07GM - Gram59088-442a66781bb-9566-4809-ae1c-284af56e1e9612021-01-08

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59088-77859088-778-00
59088-44359088-443-03
59088-44259088-442-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MiconatateMICONAZOLE NITRATE AND TOLNAFTATEPureTek Corporationc45c8f8f-9042-a428-e053-2a95a90acda92024-10-16WarningsExact identifier
ndc (package): 59088-778-00
ndc (package): 59088-442-07
ndc (package): 59088-443-03
ndc (product): 59088-778
ndc11 (package): 59088077800
ndc11 (package): 59088044207
ndc11 (package): 59088044303
spl id: 249cf0cd-2c2a-95a1-e063-6394a90af393
spl set id: c45c8f8f-9042-a428-e053-2a95a90acda9
Mycozyl ALTOLNAFTATEPureTek Corporationb82c9a8a-f6f1-dca6-e053-2995a90a47f92024-10-02WarningsExact identifier
ndc (package): 59088-443-03
ndc (product): 59088-443
ndc11 (package): 59088044303
Mycozyl APMICONAZOLE NITRATEPureTek Corporationb3c46a30-7ff2-0dc4-e053-2995a90aa5712024-10-01WarningsExact identifier
ndc (package): 59088-442-07
ndc (product): 59088-442
ndc11 (package): 59088044207
Mycozyl ALTOLNAFTATEPURETEK CORPORATION07edd043-4ac4-b2de-e063-6394a90af25d2023-10-17Warnings, Adverse reactionsExact identifier
ndc (product): 59088-443

Reported adverse events (FAERS/openFDA)#

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