Label: BIO SPECTRA ATTITUDE- sodium fluoride and potassium nitrate paste, dentifrice
- NDC Code(s): 61649-733-01
- Packager: 9055-7588 Quebec Inc. DBA Attitude
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 26, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
- Builds protection against sensitivity of the teeth.
- Shields and soothes dental nerves for lasting sensitivity relief when used regularly.
- Prevents, fights and protects against cavities.
- Effective fluoride protection.
- Protects teeth from acid erosion.
- Penetrates tooth enamel to help rebuild weak spots.
- Warnings
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Directions
Do not swallow. Should be used as part of an oral health program that includes regular flossing and dental check-ups. Brush teeth thoroughly for at least 1 minute twice a day, preferably after each meal, or as directed by a dentist or health care professional. Not recommended for children under 12 years of age. Store at room temperature (15-30 °C).
- Non-medicinal ingredients
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- PRINCIPAL DISPLAY PANEL - 120 g Tube Label
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INGREDIENTS AND APPEARANCE
BIO SPECTRA ATTITUDE
sodium fluoride and potassium nitrate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61649-733 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 0.243 g in 100 g POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 5 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) HYDRATED SILICA (UNII: Y6O7T4G8P9) GLYCERIN (UNII: PDC6A3C0OX) SODIUM LAURYL SULFATE (UNII: 368GB5141J) METHYL SALICYLATE (UNII: LAV5U5022Y) XANTHAN GUM (UNII: TTV12P4NEE) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) REBAUDIOSIDE A (UNII: B3FUD0528F) SODIUM BENZOATE (UNII: OJ245FE5EU) CARICA PAPAYA LEAF (UNII: 66J7636Z2I) GREEN TEA LEAF (UNII: W2ZU1RY8B0) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) Product Characteristics Color white (Opaque) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61649-733-01 120 g in 1 TUBE; Type 0: Not a Combination Product 04/26/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 04/26/2024 Labeler - 9055-7588 Quebec Inc. DBA Attitude (201137051) Establishment Name Address ID/FEI Business Operations 9055-7588 Quebec Inc. DBA Attitude 204307099 manufacture(61649-733) , label(61649-733) , pack(61649-733) , analysis(61649-733)
