Ionite Apf Gel
FDA Label NDC 53045-237

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 53045-237). 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, 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
  • Ionite APF Gel is free of gluten, soymilk, egg peanut and free of nut products

Inactive Ingredient


Citric Acid, Flavor, Hydrofluoric Acid, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Potassium Hydroxide, Purified Water, Sodium Benzoate, Sodium Saccharin, Sweetness Enhancer, Titanium Dioxide, Tocopheryl Acetate, Xantham Gum, Xylitol.

Warnings And Precautions

  • Keep out of the reach of children.
  • Do not swallow. If product is accidentally swallowed in quantities greater than would normally occur with a treatment gel, seek medical help or contact a Poison Control Center right away.
  • Do not use on patients with an allergy Fluoride.
  • For professional use only.

Instructions For Use

  • Shake well before use.
  • This is a four minute or one minute Fluoride gel for in-office patient use.
  • For best results, use at least twice a year.
  • After thorough prophylaxis, fill two single or one dual tray one third full with gel. Air dry teeth and insert trays into the mouth.
  • Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness)
  • Remove trays, instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes

Package Label.Principal Display Panel

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