Label: OPALESCENCE SENSITIVITY RELIEF WHITENING- potassium nitrate and sodium fluoride gel, dentifrice
51206-308-04, view more51206-308-05, 51206-308-06
- Packager: Ultradent Products, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 3, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or doctor.
- Adults and children 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth.
- Children under 12 years of age: Consult a dentist or doctor.
- Other Information
- Inactive Ingredients
- Questions or comments
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 133 g Tube Carton
INGREDIENTS AND APPEARANCE
OPALESCENCE SENSITIVITY RELIEF WHITENING
potassium nitrate and sodium fluoride gel, dentifrice
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51206-308 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Potassium Nitrate (UNII: RU45X2JN0Z) (Nitrate Ion - UNII:T93E9Y2844) Potassium Nitrate 50 mg in 1 g Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 1.1 mg in 1 g Inactive Ingredients Ingredient Name Strength Glycerin (UNII: PDC6A3C0OX) Xanthan Gum (UNII: TTV12P4NEE) Water (UNII: 059QF0KO0R) Sorbitol (UNII: 506T60A25R) Sodium Hydroxide (UNII: 55X04QC32I) Xylitol (UNII: VCQ006KQ1E) Sodium Benzoate (UNII: OJ245FE5EU) Sucralose (UNII: 96K6UQ3ZD4) Silicon Dioxide (UNII: ETJ7Z6XBU4) Methyl Salicylate (UNII: LAV5U5022Y) Sodium Lauryl Sulfate (UNII: 368GB5141J) Product Characteristics Color GREEN Score Shape Size Flavor MINT (Cool Mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51206-308-01 1 in 1 CARTON 11/30/2015 1 28.35 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:51206-308-05 24 in 1 PACKAGE, COMBINATION 11/30/2015 2 NDC:51206-308-01 1 in 1 CARTON 2 28.35 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:51206-308-02 1 in 1 CARTON 11/30/2015 3 133 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:51206-308-03 3 in 1 PACKAGE, COMBINATION 11/30/2015 4 NDC:51206-308-02 1 in 1 CARTON 4 133 g in 1 TUBE; Type 0: Not a Combination Product 5 NDC:51206-308-04 12 in 1 PACKAGE, COMBINATION 11/30/2015 5 NDC:51206-308-02 1 in 1 CARTON 5 133 g in 1 TUBE; Type 0: Not a Combination Product 6 NDC:51206-308-06 6 in 1 PACKAGE, COMBINATION 11/30/2015 6 NDC:51206-308-02 1 in 1 CARTON 6 133 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part356 11/30/2015 Labeler - Ultradent Products, Inc. (013369913) Establishment Name Address ID/FEI Business Operations OraTech, LLC 827869285 MANUFACTURE(51206-308) , ANALYSIS(51206-308) , LABEL(51206-308) , PACK(51206-308)