PRO-SYS- potassium nitrate, sodium fluoride paste, dentifrice

Drug Labeling and Warnings

Drug Details [pdf]

Inactive Ingredients

Sorbitol, Hydrated Silica, Water, Glycerin, PEG-12, Titanium Dioxide, Flavor, Sodium Lauryl Sulfate, Cellulose Gum, Xylitol, Sodium Benzoate, Disodium Phosphate, Sodium Saccharin

Indications

PRO-SYS Professional is a self-applied dentifrice 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.

Principal Display Panel

PRO-SYS®
PROFESSIONAL
ANTI-CAVITY FLUORIDE TOOTHPASTE
RX ONLY 5000 PPM 1.1% SODIUM FLUORIDE 5% POTASSIUM NITRATE
SENSITIVE
MINT, 4 OZ. (113G)
BENCO DENTAL

INGREDIENTS AND APPEARANCE

PRO-SYS 
potassium nitrate, sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 66975-778
Route of Administration	DENTAL, ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	5 g  in 100 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	1.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE GUM (UNII: K679OBS311)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
PEG-12 (UNII: NL4J9F21N9)
WATER (UNII: 059QF0KO0R)
DISODIUM PHOSPHATE (UNII: 22ADO53M6F)
SODIUM SACCHARIN (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66975-778-01	113 g in 1 TUBE; Type 0: Not a Combination Product	12/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/01/2025

Labeler - Benco Dental (015108087)