FDA.reportPublic FDA data

Micotrin AL

Manufacturer
PureTek Corporation
Effective date
2024-10-02
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:22:35

Label at a glance#

ProductMicotrin AL
Active ingredientTOLNAFTATE
Label structure9 sections

Indications and uses

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 re...

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) 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 s...

Label contents#

Full prescribing information#

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

Micotrin AL™Antifungal Liquid is supplied in a 1 fl oz / 30 mL glass bottle with a screw cap fitted with a brush applicator (NDC 59088-477-03)

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.

Micotrin AL™

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Manufactured 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
313423tolnaftate 1 % Topical SolutionPSN4
313423tolnaftate 10 MG/ML Topical SolutionSCD4
313423tolnaftate 1 % Topical SolutionSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-477-03Micotrin AL30 mL in 1 BOTTLE, WITH APPLICATORLIQUID304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-477MICOTRIN AL (TOLNAFTATE) LIQUID [PURETEK CORPORATION]4Current NDC, Legacy NDC, 1 package rows20241004_cc0fba1e-82c5-42fd-e053-2995a90af249.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-477-03ML - Milliliter59088-47787b99d43-7e93-4280-8231-c5b9ed349ca712021-11-09

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
59088-47759088-477-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
LAVENDER OILZBP1YXW0H8IACT
TEA TREE OILVIF565UC2GIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
TOLNAFTATE06KB629TKVACTIB
APPLE CIDER VINEGAR0UE22Q87VCIACT
ARGAN OIL4V59G5UW9XIACT
BENZYL ALCOHOLLKG8494WBHIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
DIMETHYL SULFOXIDEYOW8V9698HIACT
EUCALYPTUS OIL2R04ONI662IACT
GLYCERINPDC6A3C0OXIACT
LAURETH-46HQ855798JIACT

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 ALTOLNAFTATEPureTek Corporationcc0fba1e-82c5-42fd-e053-2995a90af2492024-10-02WarningsExact identifier
ndc (package): 59088-477-03
ndc (product): 59088-477
ndc11 (package): 59088047703
spl id: 2383dd56-71bf-4587-e063-6394a90a787e
spl set id: cc0fba1e-82c5-42fd-e053-2995a90af249

Reported adverse events (FAERS/openFDA)#

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