Frenna Ac Solution
FDA Label NDC 53045-300

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dharma Research, Inc. for the product Frenna Ac (NDC 53045-300). 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 storage and handling, inactive ingredient, warnings and precautions, instructions for use, package label.principal display panel, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Storage And Handling

  • Store at 59o - 86oF (15o - 30oC)
  • Protect from freezing

Inactive Ingredient

Benzyl Alcohol, Distilled Water, Potassium Chloride, Propylene Glycol.

Warnings And Precautions

  • Discontinue use if irritation appears.
  • For topical application only.
  • Avoid eye contact.
  • Do not use in patients with a known history of hyper sensetivity to Aluminum Chloride.
  • For professional use only.
  • Federal law restricts this product to sale or use on the order of a dentist.

Instructions For Use

  • Soak a cotton tipped applicator with Frenna AC.
  • Apply to bleeding area with pressure until bleeding is stopped. Should a small dark coagulum appear, flush it away with water. This will have no effect on hemostatic action.
  • Remove the impregnated cord from sulcus.
  • Flush with water and dry with air. If hemostasis is not achieved, repeat application.
  • Rinse with water and air dry until bleeding is no longer present.

Package Label.Principal Display Panel

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Indications & Usage

Frenna AC is a topical astringent solution of Aluminum Chloride. Gingival retraction can be achieved using a plain gingival retraction cord moistened with Frenna AC. Stops gingival bleeding fast. If you should anadvertently damage the gingival margin during tooth preparation or while placing a strip, a band, or a cervical matrix, moisten the area with Frenna AC which will control and stop bleeding quickly. Frenna AC contains no epinephrine. The use of casoconstrictors for gingival retractions and bleeding is potentially dangerous and should be avoided.

A plain gingival retraction cord can be dipped in Frenna AC solution and then placed into the gingival sulcus for its hemostatic action.

* Please review the disclaimer below.