FDA Label for Opalescence Whitening
View Indications, Usage & Precautions
Opalescence Whitening Product Label
The following document was submitted to the FDA by the labeler of this product Ultradent Products, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Sodium Fluoride 0.25%w/w
Purpose
Anticavity
Use
aids in the prevention of dental decay.
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. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing.) Supervise children as necessary until capable of using without supervision.
Children under 2 years of age: Consult a dentist or doctor.
Inactive Ingredients
Glycerin, Water (aqua), Silica, Sorbitol, Xylitol, Flavor (aroma), Poloxamer, Sodium Lauryl Sulfate, Carbomer, FD&C Blue#1 (CI 42090), FD&C Yellow#5 (CI 19140), Sodium Benzoate, Sodium Hydroxide, Sparkle (CI 77019, CI 77891), Sucralose, Xanthan Gum
Principal Display Panel - 133G Box
Opalescence ®
whitening toothpaste
Cool Mint with Fluoride
NET WT. 4.7 oz 133g
* Please review the disclaimer below.