Label: OPALESCENCE SENSITIVITY RELIEF WHITENING- potassium nitrate and sodium fluoride gel, dentifrice

  • NDC Code(s): 51206-308-01, 51206-308-02, 51206-308-03, 51206-308-04, view more
    51206-308-05, 51206-308-06
  • Packager: Ultradent Products, Inc.
  • Category: HUMAN OTC DRUG LABEL

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

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Potassium Nitrate 5% w/wAntihypersensitivity
    Sodium Fluoride 0.25% w/wAnticavity
  • Uses

    • Helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
    • Aids in the prevention of dental cavities.
  • Warnings

    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.

    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 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

    • 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

    Water (Aqua), Silica, Xylitol, Glycerin, Sorbitol, Flavor (Aroma), Poloxamer 407, Sodium Lauryl Sulfate, Carbomer, Sodium Benzoate, Sodium Hydroxide, Sucralose, Xanthan Gum, FD&C Blue No. 1 (CI 42090), FD&C Yellow No. 5 (CI 19140)

  • Questions or comments

    Call toll-free 1.800.552.5512

  • SPL UNCLASSIFIED SECTION

    Manufactured by: Ultradent Products, Inc., South Jordan, UT 84095, USA

  • PRINCIPAL DISPLAY PANEL - 133 g Tube Carton

    Opalescence™
    whitening toothpaste

    Cool Mint
    Sensitivity
    Relief

    NET WT. 4.7 oz • 133 g • 100 ml

    FLUORIDE TOOTHPASTE
    FOR SENSITIVE TEETH

    PRINCIPAL DISPLAY PANEL - 133 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    OPALESCENCE SENSITIVITY RELIEF WHITENING 
    potassium nitrate and sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51206-308
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Potassium Nitrate (UNII: RU45X2JN0Z) (Nitrate Ion - UNII:T93E9Y2844) Potassium Nitrate50 mg  in 1 g
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion1.1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorGREENScore    
    ShapeSize
    FlavorMINT (Cool Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51206-308-011 in 1 CARTON11/30/2015
    128.35 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:51206-308-0524 in 1 PACKAGE, COMBINATION11/30/2015
    2NDC:51206-308-011 in 1 CARTON
    228.35 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:51206-308-021 in 1 CARTON11/30/2015
    3133 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:51206-308-033 in 1 PACKAGE, COMBINATION11/30/2015
    4NDC:51206-308-021 in 1 CARTON
    4133 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:51206-308-0412 in 1 PACKAGE, COMBINATION11/30/2015
    5NDC:51206-308-021 in 1 CARTON
    5133 g in 1 TUBE; Type 0: Not a Combination Product
    6NDC:51206-308-066 in 1 PACKAGE, COMBINATION11/30/2015
    6NDC:51206-308-021 in 1 CARTON
    6133 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35611/30/2015
    Labeler - Ultradent Products, Inc. (013369913)
    Establishment
    NameAddressID/FEIBusiness Operations
    OraTech, LLC827869285MANUFACTURE(51206-308) , ANALYSIS(51206-308) , LABEL(51206-308) , PACK(51206-308)
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