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

  • NDC Code(s): 51206-309-01, 51206-309-02, 51206-309-03
  • 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 January 7, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Potassium Nitrate 5% w/wAnti-sensitivity
    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. 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 1-800-526-6880

  • SPL UNCLASSIFIED SECTION

    Manufactured by: OraTech, LLC
    10075 South Jordan Gateway, South Jordan, UT 84095

  • PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

    ALORA™

    WHITENING
    TOOTHPASTE

    SENSITIVITY

    MINT

    FLUORIDE TOOTHPASTE FOR
    SENSITIVE TEETH
    NET WT. 4 oz • 113 g

    PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    ALORA   SENSITIVITY WHITENING
    potassium nitrate and sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51206-309
    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 Ion2.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Glycerin (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    Methyl Salicylate (UNII: LAV5U5022Y)  
    Poloxamer 407 (UNII: TUF2IVW3M2)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    ColorGREENScore    
    ShapeSize
    FlavorMINT (Cool Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51206-309-023 in 1 PACKAGE, COMBINATION10/01/2019
    1NDC:51206-309-011 in 1 CARTON
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:51206-309-036 in 1 PACKAGE, COMBINATION10/01/2019
    2NDC:51206-309-011 in 1 CARTON
    2113 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 FINALpart35610/01/2019
    Labeler - Ultradent Products, Inc (013369913)
    Establishment
    NameAddressID/FEIBusiness Operations
    OraTech, LLC827869285MANUFACTURE(51206-309) , ANALYSIS(51206-309) , LABEL(51206-309) , PACK(51206-309)
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