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

  • 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 September 18, 2019

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  • SPL UNCLASSIFIED SECTION
    Drug Facts
  • ACTIVE INGREDIENT
    Active IngredientsPurpose - Sodium Fluoride 0.25% w/wAnticavity - Potassium Nitrate 5% w/wAnti-sensitivity
  • Uses
    Aids in the prevention of dental cavities. Helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
  • 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 ...
  • 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 ...
  • 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
    Carboxypolymethylene, FD&C Blue #1 (CI 42090), FD&C Yellow #5 (CI 19140), Flavor (aroma), Glycerin, Methyl Salicylate, Poloxamer 407, Potassium Nitrate, Silicon Dioxide, Sodium Benzoate, Sodium ...
  • 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 - NET WT. 4 oz • 113 g
  • INGREDIENTS AND APPEARANCE
    Product Information
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