Active Ingredient
Sodium Fluoride 0.24% w/w (0.15% w/v Fluoride Ion)
Potassium Nitrate 5%
Pro-sys Paste, Dentifrice
FDA Label NDC 66975-780
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 66975-780). 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 active ingredient, inactive ingredients, purpose, uses, warnings, directions, questions or comments?, keep out of reach of children under 6 years of age., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
- Consult a dentist or doctor.
Children under 12 years of age:
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
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