Inactive Ingredients
Sorbitol, Hydrated Silica, Water, Glycerin, PEG-12, Titanium Dioxide, Flavor, Sodium Lauryl Sulfate, Cellulose Gum, Xylitol, Sodium Benzoate, Disodium Phosphate, Sodium Saccharin
Pro-sys Paste, Dentifrice
FDA Label NDC 66975-778
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 66975-778). 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 inactive ingredients, indications, warnings, 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
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
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