FDA Label for Tanda Pearl Professional Whitening

View Indications, Usage & Precautions

Tanda Pearl Professional Whitening Product Label

The following document was submitted to the FDA by the labeler of this product Syneron Beauty 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.

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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


* Please review the disclaimer below.