Klearactil
FDA Label NDC 69492-012

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 Klearactil (NDC 69492-012). 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 representative sample image of carton/container label, 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 directions 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, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Representative Sample Image Of Carton/Container Label

Container label.jpg

General view of inner container label

Package label.jpg

General view of box content of labeling

Detail Showing Active Ingredient From Package

Active ibgredients_001.jpg

Information shown both on container label and paclage

Detail Showing Inactive Ingredient From Package

Inactive ingredients.jpg

Information shown both on container label and paclage

Detail Showing Purpose Within Active Ingredients From Package

Purpose.jpg

Information shown both on container label and package

Image Description (Purpose)

Image Description (Purpose)

Detail Showing Instructions For Use And Named Directions From Package

indications_001.jpg

Information shown both on container label and package

Image Description (Indications 001)

Image Description (Indications 001)

Detail Showing Dosage And Administration Within Directions From Package

Dosage and administration.jpg

Information shown both on container lable and package

Detail Showing Warnings From Package

Warnings.jpg

nformation shown both on container label and package

Image Description (Warnings)

Image Description (Warnings)

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

Keep out of reach of Childreb.jpg

Information shown on package

Detail Showing Questions From Package

Questions.jpg

Information shown both on container label and package

Image Description (Questions)

Image Description (Questions)

Etail Showing Other Safety Information From Package

Other safety information.jpg

nformation shown both on container label and package

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