Label: ATTITUDE ADULT FLUORIDE-FREE - SENSITIVE - SPEARMINT- potassium nitrate gel, dentifrice
- NDC Code(s): 61649-743-01
- Packager: 9055-7588 Québec Inc. DBA Attitude
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated May 14, 2024
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- SPL UNCLASSIFIED SECTION
- Medicinal ingredient
- Purpose
- Uses
- Warnings
- STOP USE
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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).
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Non-medicinal ingredients
Aqua / Water / Eau, Sorbitol, Hydrated Silica, Glycerin, Sodium Methyl Cocoyl Taurate, Gaultheria Procumbens (Wintergreen) Leaf Oil, Xanthan Gum, Sodium Chloride, Citric Acid, Rebaudioside A, Sodium Benzoate, Potassium Sorbate, Carica Papaya (Papaya) Leaf Extract, Camellia Sinensis (Tea) Leaf Extract.
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- PRINCIPAL DISPLAY PANEL - 120 g Tube Label
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INGREDIENTS AND APPEARANCE
ATTITUDE ADULT FLUORIDE-FREE - SENSITIVE - SPEARMINT
potassium nitrate gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61649-743 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 5 g in 100 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) HYDRATED SILICA (UNII: Y6O7T4G8P9) SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G) 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) SODIUM CHLORIDE (UNII: 451W47IQ8X) 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:61649-743-01 120 g in 1 TUBE; Type 0: Not a Combination Product 06/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 06/01/2022 Labeler - 9055-7588 Québec Inc. DBA Attitude (201137051) Establishment Name Address ID/FEI Business Operations 9055-7588 Québec Inc. DBA Attitude 204307099 manufacture(61649-743) , label(61649-743) , pack(61649-743) , analysis(61649-743)