PRO-SYS

Manufacturer: Benco Dental
Effective date: 2025-12-01
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:16:03

Label at a glance#

ProductPRO-SYS

Active ingredientSODIUM FLUORIDE, POTASSIUM NITRATE

Label structure5 sections

Indications and uses

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

Dosage and administration

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 ...

Label contents#

Full prescribing information#

Indications and Usage

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

• Do not swallow

• For topical use only
• As with all medications, keep out of reach of children

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Directions: Use as Directed

DOSAGE & ADMINISTRATION SECTION

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

PACKAGE LABEL.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)

SODIUM LAURYL SULFATE FREE
BENCO DENTAL

TubeBox

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
637365	potassium nitrate 5 % / sodium fluoride 1.1 % Toothpaste	PSN	2
637365	potassium nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG Toothpaste	SCD	2
637365	K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG Toothpaste	SY	2
637365	Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG Toothpaste	SY	2
637365	potassium nitrate 5 % / sodium fluoride 1.1 % Gel Toothpaste	SY	2

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Data code	Code 39	6371-455		PM5920 Rev000.jpg, PM5924 Rev000.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66975-779-01	PRO-SYS	113 g in 1 TUBE	PASTE, DENTIFRICE	113		2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

PRO-SYS
Professional Sensitivity, SLS Free - Mint (5000 ppm)
SODIUM FLUORIDE
FLUORIDE ION
XYLITOL
SODIUM BENZOATE
DISODIUM PHOSPHATE
SODIUM SACCHARIN
POTASSIUM NITRATE
NITRATE ION
HYDRATED SILICA
TITANIUM DIOXIDE
SORBITOL
COCAMIDOPROPYL BETAINE
GLYCERIN
PEG-12
CELLULOSE GUM
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
66975-779	66975-779-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM FLUORIDE	8ZYQ1474W7	ACTIB
XYLITOL	VCQ006KQ1E	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
DISODIUM PHOSPHATE	22ADO53M6F	IACT
SODIUM SACCHARIN	SB8ZUX40TY	IACT
POTASSIUM NITRATE	RU45X2JN0Z	ACTIB
HYDRATED SILICA	Y6O7T4G8P9	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
SORBITOL	506T60A25R	IACT
COCAMIDOPROPYL BETAINE	5OCF3O11KX	IACT
GLYCERIN	PDC6A3C0OX	IACT
PEG-12	NL4J9F21N9	IACT
CELLULOSE GUM	K679OBS311	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PRO-SYS	PROFESSIONAL SENSITIVITY, SLS FREE - MINT (5000 PPM)	Benco Dental	4e4761d7-f1ab-aae4-e063-6294a90a214c	2025-12-01	Warnings	Exact identifier ndc (package): 66975-779-01 ndc (product): 66975-779 ndc11 (package): 66975077901 spl id: 500d975b-b5ef-fc25-e063-6294a90a8377 spl set id: 4e4761d7-f1ab-aae4-e063-6294a90a214c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.