Ionite Apf Aerosol, Foam
FDA Label NDC 53045-252

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 Ionite Apf (NDC 53045-252). 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 inactive ingredient, warnings and precautions, instructions for use, package label.principal display panel, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Inactive Ingredient

Castor Oil, Decyl Glucoside, Distilled Water, Flavor, Hydrofluoric Acid, Phosphoric Acid, Poloxamer, Propellant A31, Sodium Benzoate, Sodium Laureth Sulface, Sodium Saccharne, Triethanolamine, Xylitol

Warnings And Precautions

  • Do not swallow.
  • Keep out of reach of children.
  • Contents under pressure.
  • Do not place in hot water or near radiators, stoves or other sources of heat.
  • Do not puncture or incinerate container. Do not spray towards open flames.
  • For professional use only.

Instructions For Use

  • Remove cap from can. Prior to each use, shake can thoroughly for at least 15 seconds.
  • To dispense,invert the can completely upside down. Slowly depress nozzle to dispense foam into a fluoride tray (foam will expand slightly higher than fluoride tray).
  • Air dry teeth thoroughly and inset tray(s) into patient's mouth. Instruct patient to bite down and leave the tray in contact with the teeth between 1 - 4 minutes.
  • Use a saliva ejector during treatment to minimize ingestion of product.
  • Remove the tray(s) and have patient expectorate.
  • Instruct patient not to eat, drink or rinse for 30 minutes after treatment.

Storage And Handling

Store at a controlled room temperature 59o-86oF (15o-30o C)

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