Tanda Pearl Professional Whitening
FDA Label NDC 46437-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Syneron Beauty Inc. for the product Tanda Pearl Professional Whitening (NDC 46437-001). 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, keep out of reach of children under 6 years of age., directions, inactive ingredients, principal display panel - 133g tube carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by Syneron Beauty Inc., 11-380 Jamieson Parkway, Cambridge, ON, N3C 4N4

Manufactured by Ultradent Products, Inc. South Jordan, Utah 84095, USA.

Active Ingredients

Sodium Fluoride 0.25% w/w

Purpose

anticavity

Uses

Aids in prevention of dental decay

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.

Inactive Ingredients

Glycerin, Water (Aqua), Silica, Sorbitol, Xylitol, Flavor (Aroma), Poloxamer, Sodium Lauryl Sulfate, Carbomer, FD&C Blue #1 (CI 42090), Sodium Benzoate, Sodium Hydroxide, Sparkle (CI 77019, CI 77891), Sucralose, and Xanthan Gum.

Principal Display Panel - 133G Tube Carton

TANDA

pearl™

professional whitening
toothpaste

NET WT 4.7 oz • 133g

Cool mint with fluoride

Principal Display Panel (133g Tube Carton)

Principal Display Panel (133g Tube Carton)

* Please review the disclaimer below.