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

PRO-SYS by

Drug Labeling and Warnings

PRO-SYS by is a Otc medication manufactured, distributed, or labeled by Benco Dental. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Sodium Fluoride 0.24% w/w (0.15% w/v Fluoride Ion)

Inactive Ingredients

Sorbitol, Hydrated Silica, Water, Glycerin, PEG 600, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Sodium Benzoate, Disodium Phosphate, Sodium Saccharin, Blue 1.

Purpose

Acticavity Toothpaste

Uses

Helps protect against cavities

Warnings

Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children under 6 years of age: use a pea-sized amount and instruct in good brushing and rinsing habits to reduce swallowing. Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.

Questions or Comments?

Distributed by Benco Dental

1-800-462-3626

Benco.com

295 CenterPoint Blvd, Pittston, PA 18640

www.PRO-SYS.com

Keep out of reach of children under 6 years of age.

Keep out of reach of children under 6 years of age.

Principal Display Panel

DENTIST RECOMMENDED

PRO-SYS®

PROFESSIONAL

FLUORIDE TOOTHGEL

MINT

0.85 OZ. (24G)

MADE IN USA

DENTIST RECOMMENDED

PRO-SYS®

PROFESSIONAL

FLUORIDE TOOTHGEL

MINT

4 OZ. (113.4G)

MADE IN USA

INGREDIENTS AND APPEARANCE

PRO-SYS 
sodium fluoride and potassium nitrate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66975-700
Route of Administration	DENTAL, ORAL

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
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
BLUE 1 (UNII: H3R47K3TBD)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
DISODIUM PHOSPHATE (UNII: 22ADO53M6F)
SODIUM SACCHARIN (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CELLULOSE GUM (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66975-700-01	113.4 g in 1 TUBE; Type 0: Not a Combination Product	12/01/2025
2	NDC: 66975-700-02	24 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
OTC Monograph Drug	M021	12/01/2025

Labeler - Benco Dental (015108087)