Opal By Opalescence Original Gel, Dentifrice
FDA Label NDC 51206-312

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 Opal By Opalescence Original (NDC 51206-312). 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, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Principal Display Panel (4.7 OZ Tube Carton)

Principal Display Panel (4.7 OZ Tube Carton)

* Please review the disclaimer below.