Active Ingredient
Sodium Fluoride 0.25%w/w
Opalescence Whitening Gel, Dentifrice
FDA Label NDC 51206-302
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ultradent Products, Inc for the product Opalescence Whitening (NDC 51206-302). 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, purpose, use, directions, inactive ingredients, principal display panel - 133g box, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Principal Display Panel (133g Box)
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