FDA.reportPublic FDA data

Submission for Bioactil Pain Relieving Gel

Manufacturer
POLIMEROS Y SERVICIOS S.A.
Effective date
2019-03-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:58:47

Label at a glance#

ProductBIOACTIL
Active ingredientMENTHOL
Label structure10 sections

Indications and uses

Uses.jpg Information shown both on container label and package

Dosage and administration

Directions.jpg Information shown both on container lable and package

Label contents#

Full prescribing information#

Detail showing Active Ingredient from package

OTC - ACTIVE INGREDIENT SECTION

Activeingredient.jpg

image descriptionimage description

Information shown both on container label and paclage

Detail showing Inactive ingredient from package

INACTIVE INGREDIENT SECTION

Inactiveingredients.jpg

image descriptionimage description

Information shown both on container label and paclage

Detail showing Purpose within Active Ingredients from package

OTC - PURPOSE SECTION

Purpose.jpgimage descriptionimage description

nformation shown both on container label and package

Detail showing Instructions for use and named Uses from package

INDICATIONS & USAGE SECTION

Uses.jpgimage descriptionimage description

Information shown both on container label and package

Detail showing Dosage and Administration within Directions from package

DOSAGE & ADMINISTRATION SECTION

Directions.jpgimage descriptionimage description

Information shown both on container lable and package

Detail showing Warnings from package

WARNINGS SECTION

Warning.jpg

image descriptionimage description

Information shown both on container label and package

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KeepoutofreachofchildrenBioactil.jpg

image descriptionimage description

Information shown on package and container label

Detail showing Questions from package

OTC - QUESTIONS SECTION

Questionsorcomments.jpg

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nformation shown both on container label and package

Detail showing Other Information from package

OTHER SAFETY INFORMATION

OtherInformation.jpgimage descriptionimage description

Information shown both on container label and package

Representative sample image of carton/container label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

General view of inner container label

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Bioactil 6 frente.jpg

Bioactilfrente.jpg

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General view of box content of labeling

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Bioactilbox.jpg

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Bioactil box.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
259150menthol 3 % Topical GelPSN2
259150menthol 0.03 MG/MG Topical GelSCD2
259150menthol 3 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69492-013-072022-01-28C16284748780-1d6a99b39-5005-a426-e053-dadaa90af4c2Submission for Bioactil Pain Relieving Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69492-013-07BIOACTIL70 g in 1 TUBEGEL702
69492-013-07BIOACTIL1 in 1 BOXGEL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69492-013BIOACTIL (PAIN RELIEVING) GEL [POLIMEROS Y SERVICIOS S.A.]2Legacy NDC, 2 package rows20190314_744d7c69-6095-4d47-8f92-b685bf5ad00e.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69492-01369492-013-07

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
MENTHOLL7T10EIP3AACTIB
ALLANTOIN344S277G0ZIACT
CARBOMER 9404Q93RCW27EIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
METHYLPARABENA2I8C7HI9TIACT
ORTHOSILICIC ACID623B93YABHIACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
PROPYLPARABENZ8IX2SC1OHIACT
SALICYLIC ACIDO414PZ4LPZIACT
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
f0e928b1-0393-415d-a74f-4620538c219a744d7c69-6095-4d47-8f92-b685bf5ad00e2019-03-13WarningsExact identifier
spl id: f0e928b1-0393-415d-a74f-4620538c219a
spl set id: 744d7c69-6095-4d47-8f92-b685bf5ad00e

Reported adverse events (FAERS/openFDA)#

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