Skip to content

Checked

Rx

Prosys

1.1% sodium fluoride · Prosys is a prescription drug containing 1.1% sodium fluoride, made by Benco Dental.

Type
Prescription
Drug class
Not classified
Route
Dental
Manufacturers
1

PRO-SYS Professional is a self-applied dentrifice for prevention of tooth decay, orthodontic decalcification and hypersensitivity.

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Uses

PRO-SYS Professional is a self-applied dentrifice for prevention of tooth decay, orthodontic decalcification and hypersensitivity.

Dosage and administration

Use as Directed This prescription dentifrice is recommended for adults and pediatric patients six years and older.

  • Apply a thin ribbon of PRO-SYS Professional along the length of the toothbrush no more than "pea size" total dose. Brush for two minutes.
  • After brushing: ADULTS-Expectorate; do not eat or drink for 30 minutes. CHILDREN SIX YEARS OF AGE OR OLDER-Expectorate and rinse mouth with water.
  • Use at bedtime in place of your regular toothpaste or as directed by your dental professional.

Warnings

Do not swallow For topical use only As with all medications, keep out of reach of children

Inactive ingredients

Water, Sorbitol, Hydrated Silica, Glycerin, PEG-12, Cellulose Gum, Xylitol, Monosodium Phosphate, Titanium Dioxide, Flavor, Sodium Saccharin, Tri-Calcium Phosphate

Questions?

For more information on the entire family of PRO-SYS oral care products, visit www.PRO-SYS.com

Forms and strengths

From the FDA NDC Directory · 1 product codes

Dosage formStrengthRouteNDCs
Paste, dentifrice.11 g/100gdental1

Side effect reports to FDA

FDA Adverse Event Reporting System (FAERS), 22 reports that list 1.1% sodium fluoride, data through 07/30/2026

Anyone can report a problem to FDA, and a report does not mean the drug caused the problem. Reports can be duplicated or incomplete, and counts depend on how widely a drug is used. Do not stop or change a medicine because of this list. Talk to your doctor or pharmacist.

Most often reported reactions

  • Dry mouth3
  • Diarrhea2
  • Oropharyngeal pain2
  • Rash2
  • Abdominal pain upper1
  • Accidental exposure to product1
  • Accidental exposure to product by child1
  • Adverse drug reaction1
  • Alanine aminotransferase increased1
  • Barrett^s esophagus1

To report a side effect, use FDA MedWatch.

Manufacturers and labels

1 FDA label

  • Benco DentalShown hereLabel 02/01/2026 · NDC 66975-782Full label

Prosys: common questions

What is Prosys used for?
PRO-SYS Professional is a self-applied dentrifice for prevention of tooth decay, orthodontic decalcification and hypersensitivity.
Is Prosys a prescription drug?
Yes. Prosys is a prescription (Rx) drug.
Are there other products with the same active ingredient as Prosys?
Yes. Other FDA-listed products with the same active ingredients include Ionite APF, Gelato Neutral pH, Ionite APF Foam, Pro-Den Rx.
Who makes Prosys?
Benco Dental lists Prosys with the FDA.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 02/01/2026 · Label text is shown as published by the manufacturer. Not medical advice