FDA.reportPublic FDA data

Polyactil N

Manufacturer
POLIMEROS Y SERVICIOS S.A.
Effective date
2019-03-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:58:47

Label at a glance#

ProductPolyactil N
Active ingredientALLANTOIN
Label structure11 sections

Dosage and administration

Information shown both on container label and package Drug Fast (continued).jpg

Label contents#

Full prescribing information#

Detail showing Active Ingredient from package

OTC - ACTIVE INGREDIENT SECTION

Information shown both on container label and paclage

image descriptionimage description

Drug fact active ingredients -.jpg

Detail showing Inactive ingredient from package

INACTIVE INGREDIENT SECTION

Information shown both on cntainer label and package

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Inactive ingredients-.jpg

Detail showing Purpose within Purposes from package

OTC - PURPOSE SECTION

Information shown both on container label and package

image descriptionimage description

Purpose .jpg

Detail showing Indications from pacage

INDICATIONS & USAGE SECTION

Information shown both on container label and package

Indicationss.jpg

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Detail shyowing Instructions for use and named Directions from package

INSTRUCTIONS FOR USE SECTION

Information shown both on container label and package

image descriptionimage description

Drug Fast (continued).jpg

Detail showing Dosage abd Administration within Directions from package

DOSAGE & ADMINISTRATION SECTION

Information shown both on container lable and package

image descriptionimage description

Dosage and ad.jpg

Detail showing Warnings from package

WARNINGS SECTION

Information shown both on container label and package

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Drug Facts Warnings.jpg

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Information shown on package

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Keep out of reach of chilfren.jpg

Detail showing Questions from package

OTC - QUESTIONS SECTION

Information shown on package

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Questions or comments.jpg

Detail showing Other Safety Information from package

OTHER SAFETY INFORMATION

Information shown both on container label and package

image descriptionimage description

Other informations-.jpg

Representative sample image of carton/container label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

General view of inner container label

Etiqueta de Polyactil - N Lunes 20 06 16.jpg

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General view of box content of labeling

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Polyactil - N Lunes 20 06 16.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69492-015-052022-01-28C16284748780-1d6a99b39-35a8-a426-e053-dadaa90af4c2Submission for Polyactil-N Skin Pritectant

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69492-015-05Polyactil N1 in 1 BOXGEL13
69492-015-05Polyactil N30 g in 1 TUBEGEL303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69492-015POLYACTIL N (SKIN PROTECTANT) GEL [POLIMEROS Y SERVICIOS S.A.]3Legacy NDC, 2 package rows20190314_f52ad131-2ecd-492d-83c7-437d703c0afc.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
69492-01569492-015-05

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
ALLANTOIN344S277G0ZACTIB
GLYCERINPDC6A3C0OXIACT
CARBOMER 9404Q93RCW27EIACT
ORTHOSILICIC ACID623B93YABHIACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
XYLITOLVCQ006KQ1EIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
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
63091851-aced-4b37-9069-3c4cbf5fc7d6f52ad131-2ecd-492d-83c7-437d703c0afc2019-03-13WarningsExact identifier
spl id: 63091851-aced-4b37-9069-3c4cbf5fc7d6
spl set id: f52ad131-2ecd-492d-83c7-437d703c0afc

Reported adverse events (FAERS/openFDA)#

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