Tolcylen Antifungal Solution

Manufacturer
Marlinz Pharma, LLC
Effective date
2022-02-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:47:55

Label at a glance#

ProductTolcylen Antifungal Solution
Active ingredientTOLNAFTATE
Label structure8 sections

Indications and uses

Cures most Athlete’s Foot (Tinea Pedis) ■ Relieves itching, cracking, burning and scaling, which accompanies this condition ■ Prevents recurrence of Athlete’s Foot

Dosage and administration

Wash the affected area with soap and water. ■ Dry thoroughly, then apply a thin layer over the affected area. ■ Use twice daily (morning and night) or as directed by a physician. ■ Pay special attention to the spaces between the toes and the areas around the edges and under the front of the nails. ■ Wear well-fitted ventilated shoes and change socks at least once daily. ■ Use daily for four (4) weeks. If condition...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Uses

INDICATIONS & USAGE SECTION

Cures most Athlete’s Foot (Tinea Pedis) ■ Relieves itching, cracking, burning and scaling, which accompanies this condition ■
Prevents recurrence of Athlete’s Foot

Warnings

WARNINGS SECTION

Do not use on children under 2 years of age ■ For external use only ■ Avoid contact with the eyes. If eye contact occurs, wash thoroughly with
water ■ Stop use and consult a physician if irritation occurs or if there is no improvement within four (4) weeks ■ Keep out of reach of children ■ If swallowed,
get medical help or contact a poison control center right away ■ If pregnant or breast-feeding, ask a health-care professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

Wash the affected area with soap and water.
■ Dry thoroughly, then apply a thin layer over the affected area.
■ Use twice daily (morning and night) or as directed by a physician.
■ Pay special attention to the spaces between the toes and the areas around the edges and under the front of the nails.
■ Wear well-fitted ventilated shoes and change socks at least once daily.
■ Use daily for four (4) weeks. If condition persists longer, consult a physician.
■ Wash hands after each use. Store and use at room temperature.

Inactive Ingredeints

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Ethyl Acetate, Isopropyl Alcohol, Isopropyl Myristate, Propylene Glycol, Water
Cosmetic Ingredients: Urea, Lactic Acid, Jojoba Oil, Undecylenic Acid, Dimethyl Isosorbide, Vitamin E

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image1Image1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1988416Tolcylen 1 % Topical SolutionPSN4
313423tolnaftate 1 % Topical SolutionPSN4
1988416tolnaftate 10 MG/ML Topical Solution [Tolcylen]SBD4
313423tolnaftate 10 MG/ML Topical SolutionSCD4
1988416Tolcylen 1 % Topical SolutionSY4
1988416Tolcylen 10 MG/ML Topical SolutionSY4
313423tolnaftate 1 % Topical SolutionSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70945-100-75Tolcylen Antifungal Solution7.5 mL in 1 TUBE, WITH APPLICATORSOLUTION7.54
70945-100-75Tolcylen Antifungal Solution1 in 1 CARTONSOLUTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70945-100TOLCYLEN ANTIFUNGAL SOLUTION (TOLNAFTATE) SOLUTION [MARLINZ PHARMA, LLC]4Legacy NDC, 2 package rows20220203_a0ae6ab7-960d-4fed-ab31-fb70882fc7e0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70945-100-75ML - Milliliter70945-1007e872db7-1ad7-43fe-bdea-05a4314a925712020-06-05

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70945-10070945-100-75

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d6f9dc73-a54c-66eb-e053-2995a90a9a89a0ae6ab7-960d-4fed-ab31-fb70882fc7e02022-02-01WarningsExact identifier
spl id: d6f9dc73-a54c-66eb-e053-2995a90a9a89
spl set id: a0ae6ab7-960d-4fed-ab31-fb70882fc7e0

Reported adverse events (FAERS/openFDA)#

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