Label: OPAL BY OPALESCENCE ORIGINAL- sodium fluoride gel, dentifrice

  • NDC Code(s): 51206-312-01, 51206-312-02
  • Packager: Ultradent Products, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 31, 2025

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION
    Drug Facts
  • Active Ingredients
    Sodium Fluoride 0.25% w/w
  • Purpose
    Anticavity
  • Uses
    Aids in the prevention of dental decay.
  • Warnings
    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 ...
  • 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) ...
  • 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
  • INGREDIENTS AND APPEARANCE
    Product Information
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!