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Opalescence Whitening Toothpaste (Ultradent Products, Inc.)

Available Formats

Dosage Form Package Information Links
GEL, DENTIFRICE 1 TUBE in 1 BOX (51206-302-06) > 133 g in 1 TUBE Label Information
GEL, DENTIFRICE 1 TUBE in 1 BOX (51206-302-07) > 28.35 g in 1 TUBE Label Information

Complete Opalescence Whitening Toothpaste Information

  • SPL UNCLASSIFIED SECTION

    Drug Facts


  • Active ingredient

    Sodium Fluoride 0.25%w/w


  • Purpose

    Anticavity


  • Use

    aids in the prevention of dental decay.


  • Warning

    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), FD&C Yellow#5 (CI 19140), Sodium Benzoate, Sodium Hydroxide, Sparkle (CI 77019, CI 77891), Sucralose, Xanthan Gum


  • SPL UNCLASSIFIED SECTION

    Manufactured by Ultradent Products, Inc.
    www.ultradent.com 800.552.5512
    South Jordan, Utah 84095, USA
    30302.11 030910


  • PRINCIPAL DISPLAY PANEL - 133g Box

    Opalescence ®
    whitening toothpaste

    Cool Mint with Fluoride

    NET WT. 4.7 oz 133g

    Principal Display Panel - 133g Box

  • INGREDIENTS AND APPEARANCE
    OPALESCENCE WHITENING 
    sodium fluoride gel, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51206-302
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 1.1 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color GREEN Score     
    Shape Size
    Flavor MINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51206-302-07 1 in 1 BOX 07/01/1994
    1 28.35 g in 1 TUBE; Type 0: Not a Combination Product
    2 NDC:51206-302-06 1 in 1 BOX 07/01/1994
    2 133 g in 1 TUBE; Type 0: Not a Combination Product
    3 NDC:51206-302-08 3 in 1 PACKAGE, COMBINATION 06/01/2016
    3 NDC:51206-302-06 1 in 1 BOX
    3 133 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 final part355 07/01/1994
    Labeler - Ultradent Products, Inc. (013369913)
    Establishment
    Name Address ID/FEI Business Operations
    Ultradent Products, Inc. 013369913 MANUFACTURE(51206-302) , ANALYSIS(51206-302) , LABEL(51206-302)