FDA.reportPublic FDA data

Lasolex AL - PureTek Corporation

Manufacturer
PureTek Corporation
Effective date
2026-06-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-06-16 05:10:23

Label at a glance#

ProductLasolex AL
Active ingredientMICONAZOLE NITRATE
Label structure9 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 weeks; for joc...

Storage and handling

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] Do not use if package is damaged Protect from freezing and excessive heat Keep container tightly closed.

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), and ringworm (tinea corporis)
  • For relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on children under 2 years of age unless directed by a doctor.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Irritation occurs or there is no improvement within 4 weeks for athlete's foot and ringworm, or 2 weeks 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 Room Temperature]
  • Do not use if package is damaged
  • Protect from freezing and excessive heat
  • Keep container tightly closed.

INACTIVE INGREDIENT SECTION

Inactive ingredients Acrylamide, Argania Spinosa (Argan) Kernel Oil, Benzyl Alcohol, Dimethyl Sulfoxide, dl-Alpha-Tocopheryl Acetate, Ethoxydiglycol, Eucalyptus Globulus (Eucalyptus) Leaf Oil, Glycerin, Isohexadecane, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, PEG-8, Polysorbate 80, Propylene Glycol, Sorbitan oleate.

SPL UNCLASSIFIED SECTION

Manufactured by:
PureTek Corporation
Panorama City, CA 91402
For questions or information
call toll-free: 1-877-921-7873

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130359088238035GTIN-13: 0359088238035
EAN-13: 0359088238035
GTIN-12: 359088238035
UPC-A: 359088238035
GTIN storage (14 digits): 00359088238035		Lasolex AL.jpg

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59088-23859088-238-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARGANIA SPINOSA KERNEL OIL4V59G5UW9XIACT
LAVANDULA ANGUSTIFOLIA (LAVENDER) OILZBP1YXW0H8IACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ISOHEXADECANE918X1OUF1EIACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILVIF565UC2GIACT
PEG-8B697894SGQIACT
MICONAZOLE NITRATEVW4H1CYW1KACTIB
BENZYL ALCOHOLLKG8494WBHIACT
ETHOXYDIGLYCOLA1A1I8X02BIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
SORBITAN OLEATE06XEA2VD56IACT
DIMETHYL SULFOXIDEYOW8V9698HIACT
POLYSORBATE 806OZP39ZG8HIACT
ACRYLAMIDE20R035KLCIIACT
EUCALYPTUS GLOBULUS LEAF OIL2R04ONI662IACT

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
Lasolex ALMICONAZOLE NITRATE 2% ANTIFUNGALPureTek Corporation534df9be-b47a-03a1-e063-6394a90a265a2026-06-02WarningsExact identifier
ndc (package): 59088-238-03
ndc (product): 59088-238
ndc11 (package): 59088023803
spl id: 534df9be-b47b-03a1-e063-6394a90a265a
spl set id: 534df9be-b47a-03a1-e063-6394a90a265a

Reported adverse events (FAERS/openFDA)#

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