Active Ingredient
Sodium Fluoride 0.24% w/w (0.15% w/v Fluoride Ion)
Pro-sys Paste, Dentifrice
FDA Label NDC 66975-700
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 66975-700). 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 600, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Sodium Benzoate, Disodium Phosphate, Sodium Saccharin, Blue 1.
Purpose
Acticavity 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 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children under 6 years of age: use a pea-sized amount and instruct in good brushing and rinsing habits to reduce swallowing. Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.
Questions Or Comments?
Distributed by Benco Dental
1-800-462-3626
Benco.com
295 CenterPoint Blvd, Pittston, PA 18640
www.PRO-SYS.com
Keep Out Of Reach Of Children Under 6 Years Of Age.
Keep out of reach of children under 6 years of age.
Principal Display Panel
DENTIST RECOMMENDED
PRO-SYS®
PROFESSIONAL
FLUORIDE TOOTHGEL
MINT
0.85 OZ. (24G)
MADE IN USA
DENTIST RECOMMENDED
PRO-SYS®
PROFESSIONAL
FLUORIDE TOOTHGEL
MINT
4 OZ. (113.4G)
MADE IN USA
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