PRO-SYS (sensitivity - mint- otc 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)

Potassium Nitrate 5%

Inactive Ingredients

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

Purpose

Anticavity 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 12 years of age and older:

• Apply at least a 1-inch strip of the product onto a soft bristle toothbrush.
• Brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.

Children under 12 years of age:

• Consult a dentist or doctor.

Questions or Comments?

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

1-800-462-3626

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

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.

Principal Display Panel

PRO-SYS®

PROFESSIONAL

ANTI-CAVITY FLUORIDE TOOTHPASTE

SENSITIVE

MINT, 0.85 OZ. (24G)

BENCO DENTAL

PRO-SYS®

PROFESSIONAL

ANTI-CAVITY FLUORIDE TOOTHPASTE

SENSITIVE

MINT, 4.0 OZ. (113G)

BENCO DENTAL

INGREDIENTS AND APPEARANCE

PRO-SYS 
sensitivity - mint (otc) paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66975-780
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)	FLUORIDE ION	0.11 g  in 100 g

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

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66975-780-01	113 g in 1 TUBE; Type 0: Not a Combination Product	12/01/2025
2	NDC: 66975-780-02	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)