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Opalescence PF (Ultradent Products, Inc.)

Available Formats

Dosage Form Package Information Links
PASTE, DENTIFRICE 1 TUBE in 1 BOX (51206-303-07) > 28.35 g in 1 TUBE Label Information
PASTE, DENTIFRICE 1 TUBE in 1 BOX (51206-303-06) > 133 g in 1 TUBE Label Information

Complete Opalescence PF Information

  • Drug Facts


  • ACTIVE INGREDIENT

    Active ingredient/Purpose

    Sodium Fluoride 0. 25%w/w (Anticavity)
    Potassium Nitrate 5%w/w


  • Uses

    Anti hypersensitivity


  • 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.

    • Stop use and ask a dentist if the problem persists or worsens.

    • Sensitive teeth may indicate a problem needing prompt care by a dentist.

    • Do not use product longer than 4 weeks unless recommended by a dentist or doctor.

  • 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 sensitvie areas of the teeth.
    • Children under 12 years of age: consult a dentist or physician.

  • Inactive Ingredients

    Water (aqua), Silica, Xylitol, Glycerin, Sorbitol, Poloxamer, Carbomer, Cocamidopropyl Amino Betaine, Flavor (aroma), Sodium Benzoate, Sodium Hydroxide, Sodium Saccharin, Sparkle (CI 77019, CI 77891), Titanium Dioxide (CI 77891), Xanthan Gum


  • PRINCIPAL DISPLAY PANEL - 28.35g carton

    For sensitive teeth

    Opalescence® PF
    whitening toothpaste

    Vanilla Mint with
    Potassium Nitrate
    and Fluoride

    NET WT. 1.0 oz 28.35g

    PRINCIPAL DISPLAY PANEL - 28.35g carton

  • INGREDIENTS AND APPEARANCE
    OPALESCENCE PF 
    sodium fluoride and potassium nitrate paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51206-303
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride 0.070875 g  in 28.35 g
    Potassium Nitrate (UNII: RU45X2JN0Z) (Potassium Cation - UNII:295O53K152) Potassium Nitrate 1.4175 g  in 28.35 g
    Inactive Ingredients
    Ingredient Name Strength
    water (UNII: 059QF0KO0R)  
    xylitol (UNII: VCQ006KQ1E)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Sorbitol (UNII: 506T60A25R)  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor MINT (Vanilla Mint) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51206-303-07 1 in 1 BOX
    1 28.35 g in 1 TUBE
    2 NDC:51206-303-06 1 in 1 BOX
    2 133 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part355 11/15/2010
    Labeler - Ultradent Products, Inc. (013369916)
    Establishment
    Name Address ID/FEI Business Operations
    Ultradent Products, Inc. 013369916 MANUFACTURE