PROSYS- 1.1% sodium fluoride paste, dentifrice

Prosys by

Drug Labeling and Warnings

Prosys by is a Prescription medication manufactured, distributed, or labeled by Benco Dental. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Inactive Ingredients

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

Indications

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

Warnings

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

Directions: 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.

Questions

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

Principal Display Panel

Dentist Recommended

PRO-SYS

Professional

Anti-Cavity Fluoride Toothpaste

Vanilla Mint 4 oz. (113g) RX ONLY

INGREDIENTS AND APPEARANCE

PROSYS 
1.1% sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 66975-782
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.11 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)
SODIUM SACCHARIN (UNII: SB8ZUX40TY)
PEG-12 (UNII: NL4J9F21N9)
XYLITOL (UNII: VCQ006KQ1E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CELLULOSE GUM (UNII: K679OBS311)
HYDRATED SILICA (UNII: Y6O7T4G8P9)

Product Characteristics
Color		Score
Shape		Size
Flavor	VANILLA, MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66975-782-01	113 g in 1 TUBE; Type 0: Not a Combination Product	02/01/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/01/2026

Labeler - Benco Dental (015108087)