Indications And Usage
PRO-SYS Professional is a self-applied dentrifice for prevention of tooth decay, orthodontic decalcification and
hypersensitivity.
Pro-sys Paste, Dentifrice
FDA Label NDC 66975-779
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Benco Dental for the product Pro-sys (NDC 66975-779). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding indications and usage, warnings, inactive ingredients, directions: use as directed, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Warnings
• Do not swallow
• For topical use only
• As with all medications, keep out of reach of children
Inactive Ingredients
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
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)
SODIUM LAURYL SULFATE FREE
BENCO DENTAL
* Please review the disclaimer below.
