Label: OPALESCENCE WHITENING- sodium fluoride gel, dentifrice

  • NDC Code(s): 51206-302-06, 51206-302-07, 51206-302-08, 51206-302-09, view more
    51206-302-10, 51206-302-11
  • Packager: Ultradent Products, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 22, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Sodium Fluoride 0.25% w/w

  • Purpose

    Anticavity

  • Uses

    Aids in the prevention of dental decay.

  • Warnings

    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.
  • 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

    Glycerin, Water (Aqua), Silica, Sorbitol, Xylitol, 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 - 100 ml Tube Box

    Opalescence™
    whitening toothpaste

    NET WT. 4.7 oz • 133 g • 100 ml
    FLUORIDE TOOTHPASTE

    Original
    Cool Mint

    Principal Display Panel - 100 ml Tube Box
  • INGREDIENTS AND APPEARANCE
    OPALESCENCE WHITENING 
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51206-302
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51206-302-071 in 1 BOX07/01/1994
    128.35 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:51206-302-1024 in 1 PACKAGE, COMBINATION06/01/2016
    21 in 1 BOX
    228.35 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:51206-302-061 in 1 BOX07/01/1994
    3133 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:51206-302-083 in 1 PACKAGE, COMBINATION06/01/2016
    41 in 1 BOX
    4133 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:51206-302-0912 in 1 PACKAGE, COMBINATION06/01/2016
    51 in 1 BOX
    5133 g in 1 TUBE; Type 0: Not a Combination Product
    6NDC:51206-302-116 in 1 PACKAGE, COMBINATION08/24/2020
    61 in 1 BOX
    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 DrugM02107/01/1994
    Labeler - Ultradent Products, Inc (013369913)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultradent Products, Inc.013369913manufacture(51206-302) , analysis(51206-302) , label(51206-302) , pack(51206-302)
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