FDA.reportPublic FDA data

Submission for KERACTIL Plus Topical Antifungal Gel

Manufacturer
POLIMEROS Y SERVICIOS S.A.
Effective date
2019-03-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:58:42

Label at a glance#

ProductKERACTIL Plus
Active ingredientTOLNAFTATE
Label structure1 sections

Label contents#

Full prescribing information#

Representative sample image of carton/container label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

General view of box content of labeling

Caja con cambios Keractil Plus.jpg

image descriptionimage description

Representative sample image of carton/container label

Keractil Fondo gris.jpg

image descriptionimage description

Detail showing Active Ingredient from package

OTC - ACTIVE INGREDIENT SECTION

Information shown both on container label and package

Active Ingredients- Keractil plus.jpg

image descriptionimage description

Detail showing Inctive Ingredient from package

INACTIVE INGREDIENT SECTION

Infiomaion shown both on content of label and package

Inactive ingredients.jpg

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Detail showing Purpose within Active Ingredients from package

OTC - PURPOSE SECTION

Information shown both on container label and package

Purpose.jpg

image descriptionimage description

Detail showing Instructions for use and named Uses from package

INDICATIONS & USAGE SECTION

Ibformation shown both on container label and package

Directions.jpg

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Detail showing Dosage and Administration within Directions from package

DOSAGE & ADMINISTRATION SECTION

Information shown both on container label and package

Dosage and administration.jpg

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Detail showing Warnings from package

WARNINGS SECTION

Information shown both on cintainer label and package

Warnings-.jpg

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Detail showing Keep Out of Reach of Children within Warnings from package

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Information shown both on cobtainer label and package

Keep out of reach of children.jpg

image descriptionimage description

Detail showing Questions from package

OTC - QUESTIONS SECTION

Information shown both on container label and package

Questions Keractil Plus.jpg

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Detail showing Other Safety Information from package

OTHER SAFETY INFORMATION

Ibformation shown both on container label and package

Other information Keractil plus.jpg

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313420tolnaftate 1 % Topical GelPSN2
313420tolnaftate 0.01 MG/MG Topical GelSCD2
313420tolnaftate 1 % Topical GelSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69492-014-062022-01-28C16284748780-1d6a99b39-8456-a426-e053-dadaa90af4c2Submission for KERACTIL Plus Topical Antifungal Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69492-014-06KERACTILPlus1 in 1 BOXGEL12
69492-014-06KERACTILPlus10 g in 1 TUBEGEL102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69492-014KERACTIL PLUS (ANTIFUNGAL) GEL [POLIMEROS Y SERVICIOS S.A.]2Legacy NDC, 2 package rows20190306_0605381a-83cf-401d-86cf-a6a41b15355e.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69492-01469492-014-06

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
TOLNAFTATE06KB629TKVACTIB
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
METHYLPARABENA2I8C7HI9TIACT
ORTHOSILICIC ACID623B93YABHIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
WATER059QF0KO0RIACT

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
f897feb9-a60e-4bb3-acd0-353f010578a30605381a-83cf-401d-86cf-a6a41b15355e2019-03-05WarningsExact identifier
spl id: f897feb9-a60e-4bb3-acd0-353f010578a3
spl set id: 0605381a-83cf-401d-86cf-a6a41b15355e

Reported adverse events (FAERS/openFDA)#

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