Anti-Fungal Liquid

Manufacturer
Qingdao Kuajie Online Electronic Technology Co., Ltd
Effective date
2024-04-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:10:32

Label at a glance#

ProductAnti-Fungal Liquid
Active ingredientTOLNAFTATE
Label structure11 sections

Storage and handling

Store at room temperature 15°-30℃(59°-86℉).

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

WATER 58.6 mL
POLIGLUSAM 3.4 g
CHLORHEXIDINE 0.2 g
PROPANEDIOL 6 g
LAUROCAPRAM 0.3 g
SALICYLIC ACID 4.7 g
SORBITOL 15 g
ANGELICA DAHURICA LEAF 1.8 g
ALCOHOL 10 mL

PURPOSE

OTC - PURPOSE SECTION

Fungal Nail Renewal

HOW TO USE

INDICATIONS & USAGE SECTION

1.Apply the product twice a day, in themorning and at night.

2.For initial use, soak the affected nail inwam water to soften it. Gently file the naito make it thinner and remove dirt. beingcautious not to harm the nail bed. Applythe product after this step.

3.After the first application, repeat ever2-3 days. File the surface of the affectednail and continue regular usage.w'In case of ingestion, seek medical.assistance or contact a poison controlcenter immediately.

WARNINGS

WARNINGS SECTION

For extemmal use only, do not ingest.

Avoid eye contact: maintaln dry and clean skin.

Exercise caution when using on severely ulcerated skin.

This product is not a substitute for medication.

Do not use on children under 2 years of age unless directed by a doctor.

STOP USE AND ASK A DOCTOR IF

OTC - STOP USE SECTION

You become pregnant or are planning.to get pregnant while using the product.

You are allergic to this product (such a itching, rash swelling of the lips, eyelidsand shortness of breath).

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

Fungal nails, Athlete's Foot, Tinea ManuumJock ltch, Ringworm caused by fungus andbacterial.

Helps prevent most athlete's foot with daily use.

For effective relief of itching, burning and cracking.

STORAGE

STORAGE AND HANDLING SECTION

Store at room temperature

15°-30℃(59°-86℉).

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep away from direct sunlight or heat!

DOSAGE

DOSAGE & ADMINISTRATION SECTION

1.Apply the product twice a day, in themorning and at night.

2.For initial use, soak the affected nail inwam water to soften it. Gently file the naito make it thinner and remove dirt. beingcautious not to harm the nail bed. Applythe product after this step.

3.After the first application, repeat ever2-3 days. File the surface of the affectednail and continue regular usage.w'In case of ingestion, seek medical.assistance or contact a poison controlcenter immediately.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tolnaftate2Tolnaftate2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313423tolnaftate 1 % Topical SolutionPSN1
313423tolnaftate 10 MG/ML Topical SolutionSCD1
313423tolnaftate 1 % Topical SolutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
84033-003-012025-07-29C16284748780-13b156c62-30ad-fb37-e063-e6dba90a4e071513d791-6b4b-1394-e063-6394a90a98a7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84033-003-01Anti-Fungal Liquid30 mL in 1 BOTTLELIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84033-003ANTI-FUNGAL LIQUID (TOLNAFTATE) LIQUID [QINGDAO KUAJIE ONLINE ELECTRONIC TECHNOLOGY CO., LTD]11 package rows20240403_1513d791-6b4b-1394-e063-6394a90a98a7.zip

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
84033-00384033-003-01

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
1513d791-6b4c-1394-e063-6394a90a98a71513d791-6b4b-1394-e063-6394a90a98a72024-04-01WarningsExact identifier
spl id: 1513d791-6b4c-1394-e063-6394a90a98a7
spl set id: 1513d791-6b4b-1394-e063-6394a90a98a7

Reported adverse events (FAERS/openFDA)#

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