Bioactil
FDA Label NDC 69492-013

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Polimeros Y Servicios S.a. for the product Bioactil (NDC 69492-013). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding detail showing active ingredient from package, detail showing inactive ingredient from package, detail showing purpose within active ingredients from package, detail showing instructions for use and named uses from package, detail showing dosage and administration within directions from package, detail showing warnings from package, detail showing keep out of reach of children within warnings from package, detail showing questions from package, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Detail Showing Active Ingredient From Package

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Image Description (Activeingredient)

Image Description (Activeingredient)

Information shown both on container label and paclage

Detail Showing Inactive Ingredient From Package

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Image Description (Inactiveingredients)

Image Description (Inactiveingredients)

Information shown both on container label and paclage

Detail Showing Purpose Within Active Ingredients From Package

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Image Description (Purpose)

Image Description (Purpose)

nformation shown both on container label and package

Detail Showing Instructions For Use And Named Uses From Package

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Image Description (Uses)

Image Description (Uses)

Information shown both on container label and package

Detail Showing Dosage And Administration Within Directions From Package

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Image Description (Directions)

Information shown both on container lable and package

Detail Showing Warnings From Package

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Image Description (Warning)

Image Description (Warning)

Information shown both on container label and package

Detail Showing Keep Out Of Reach Of Children Within Warnings From Package

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Image Description (Keepoutofreachofchildrenbioactil)

Information shown on package and container label

Detail Showing Questions From Package

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Image Description (Questionsorcomments)

nformation shown both on container label and package

Detail Showing Other Information From Package

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Image Description (Otherinformation)

Image Description (Otherinformation)

Information shown both on container label and package

Representative Sample Image Of Carton/Container Label

General view of inner container label

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General view of box content of labeling

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Image Description (Bioactilbox)

Image Description (Bioactilbox)

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