![TANDA PEARL PROFESSIONAL WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [SYNERON BEAUTY INC.]](https://medic.hrt.org//dailymed/images/aff575a3-05af-49ec-92d4-d9d366779350/tanda-pearl-01.jpg)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warning
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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
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 133g Tube Carton
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INGREDIENTS AND APPEARANCE
TANDA PEARL PROFESSIONAL WHITENING
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46437-001 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride ion - UNII:Q80VPU408O) Sodium Fluoride 0.33 g in 133 g Inactive Ingredients Ingredient Name Strength Glycerin (UNII: PDC6A3C0OX) Water (UNII: 059QF0KO0R) Silicon Dioxide (UNII: ETJ7Z6XBU4) Sorbitol (UNII: 506T60A25R) Xylitol (UNII: VCQ006KQ1E) Methyl Salicylate (UNII: LAV5U5022Y) Sodium Lauryl Sulfate (UNII: 368GB5141J) FD&C Blue NO. 1 (UNII: H3R47K3TBD) Sodium Benzoate (UNII: OJ245FE5EU) Sodium Hydroxide (UNII: 55X04QC32I) Sucralose (UNII: 96K6UQ3ZD4) Xanthan Gum (UNII: TTV12P4NEE) Product Characteristics Color BLUE Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46437-001-01 1 in 1 BOX 1 133 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part355 08/03/2012 Labeler - Syneron Beauty Inc. (248047115)
