FDA Label for Opal By Opalescence Original
View Indications, Usage & Precautions
Opal By Opalescence Original 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.
Other
Drug Facts
Active Ingredients
Sodium Fluoride 0.25% 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. 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, Water (Aqua), Silica, Sorbitol, Xylitol, Methyl Salicylate (flavor), Poloxamer 407, Sodium Lauryl Sulfate, Carbomer, Cool Mint Flavor, FD&C Blue #1 (CI 42090), FD&C Yellow #5 (CI 19140), Wintermint Flavor, Sodium Benzoate, Sodium Hydroxide, Sucralose, Xantham Gum
Questions Or Comments
Call toll-free 1.800.496.8330
Principal Display Panel - 4.7 Oz Tube Carton
opal™
by Opalescence®
Whitening
Toothpaste
ORIGINAL
COOL MINT
FLUORIDE TOOTHPASTE
NET WT. 4.7 OZ
* Please review the disclaimer below.