Miconazole Nitrate 2% Antifungal Gel

Manufacturer
Puretek Corporation
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:30:07

Label at a glance#

ProductLasolex AG
Active ingredientMICONAZOLE NITRATE
Label structure12 sections

Indications and uses

For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis) For relief of itching, scaling, cracking, burning, redness, soreness, irritation, 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 ...

Storage and handling

Store at 20° to 25°C (68° to 77°F) [see USP Controlled RoomTemperature]. Avoid excessive heat. Do not use if package is damaged.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2%

Purpose

OTC - PURPOSE SECTION

Anti-Fungal

Uses

INDICATIONS & USAGE SECTION

  • For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
  • For relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort

Warnings

WARNINGS SECTION

For external use only. Not for opthalmic use.

Do not use

OTC - DO NOT USE SECTION

on children under 2 years of age unless directed by Doctor.

When using this product

OTC - WHEN USING SECTION

Avoid contact with eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor (for athlete's foot and ringworm)
  • irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a doctor (for jock itch)

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

● 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 persists longer, consult a doctor.

● This product is not effective on the scalp or nails.

Other Information

STORAGE AND HANDLING SECTION

Store at 20° to 25°C (68° to 77°F) [see USP Controlled RoomTemperature]. Avoid excessive heat. Do not use if package is damaged.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Caprylyl Glycol, Dimethicone, Dimethyl Sulfoxide, Dimethicone Crosspolymer, Ethylhexylglycerin, Glycerin, Hexylene Glycol, Hydroxyethylcellulose, PEG-4, Phenoxyethanol, Propylene Glycol, Sodium Hyaluronate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2735135Lasolex 2 % Topical GelPSN5
998437miconazole nitrate 2 % Topical GelPSN5
2735135miconazole nitrate 0.02 MG/MG Topical Gel [Lasolex]SBD5
998437miconazole nitrate 0.02 MG/MG Topical GelSCD5
2735135Lasolex 0.02 MG/MG Topical GelSY5
2735135Lasolex 2 % Topical GelSY5
998437miconazole nitrate 2 % Topical GelSY5

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
59088-207-07Lasolex AG85 g in 1 TUBEGEL855

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-207-07GM - Gram59088-207c0429a15-b9c9-4029-a7a7-e056c9fc6bbb12026-01-08

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59088-20759088-207-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-12-22monthly-update2026-06-03 17:46:32

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
Lasolex AGMICONAZOLE NITRATEPuretek Corporation4411142f-a8ec-c8c2-e063-6394a90aa25c2025-12-31WarningsExact identifier
ndc (package): 59088-207-07
ndc (product): 59088-207
ndc11 (package): 59088020707
spl id: 474761d7-e86c-6f50-e063-6394a90a07b4
spl set id: 4411142f-a8ec-c8c2-e063-6394a90aa25c

Reported adverse events (FAERS/openFDA)#

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