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Drug Facts
Opalescence Whitening Original Cool Mint Gel, Dentifrice
FDA Label NDC 51206-450
11 label sections · Submitted to the FDA by Ultradent Products, Inc. · 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 Original Cool Mint (NDC 51206-450). 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 other, active ingredients, purpose, uses, otc - keep out of reach of children, warnings, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Sodium Fluoride 0.24% w/w
Purpose
Anticavity
Uses
Aids in the prevention of dental decay
Otc - Keep Out Of Reach Of Children
Keep out of reach of children under 6 years of age.
Warnings
If more than used for brushing is accidentally swallowed, 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. 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.
Other Information
- Do not use if tamper-evident seal is broken
- Store at room temperature
- Contains FD&C Yellow No. 5 (tartrazine) as a color additive
Inactive Ingredients
Glycerin, Aqua (Water), Silica, Sorbitol, Xylitol, Methyl Salicylate, Poloxamer 407, Sodium Lauryl Sulfate, Carbomer, FD&C Blue No. 1 (CI 42090), FD&C Yellow No. 5 (CI 19140), Flavor (Aroma), Sodium Benozoate, Sodium Hydroxide, Sucralose, Xanthan Gum
Questions Or Comments
Call toll-free 1.800.552.5512
Principal Display Panel
Opalescence Whitening Toothpaste
Original
Cool Mint
Fluoride Toothpaste
NET Wt. 4.7 oz
Opalescence Whitening Toothpaste
Original
Cool Mint
Fluoride Toothpaste
NET WT 4.7 oz * 133 g * 100 ml
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