Label: BIO SPECTRA ATTITUDE- sodium fluoride gel, dentifrice
- NDC Code(s): 61649-723-01
- Packager: Attitude DBA 9055-7588 Québec Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 August 29, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
-
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. Children under 6 years of age should use only a pea-sized amount and be supervised to brush properly and to not swallow. Consult a dentist or health care professional before using with children under 2 years of age. Store at room temperature (15-30 °C).
-
Inactive ingredients
Aqua / Water /Eau, Sorbitol, Glycerin, Hydrated Silica, Sodium Lauryl Sulfate, Xanthan Gum, Citric Acid, Stevia Rebaudiana Leaf/Stem Extract, Sodium Benzoate, Potassium Sorbate, Camellia Sinensis (Green Tea) Leaf Extract, Carica Papaya (Papaya) Leaf Extract, Alpha-Ionone*, Butyl Isovalerate*, Caprylic/Capric Triglyceride*, Ethyl Butyrate*, Gamma-Decalactone*, *Flavour (Aroma).
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 120 g Tube Label
-
INGREDIENTS AND APPEARANCE
BIO SPECTRA ATTITUDE
sodium fluoride gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61649-723 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 Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) HYDRATED SILICA (UNII: Y6O7T4G8P9) SODIUM LAURYL SULFATE (UNII: 368GB5141J) XANTHAN GUM (UNII: TTV12P4NEE) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876) SODIUM BENZOATE (UNII: OJ245FE5EU) CARICA PAPAYA LEAF (UNII: 66J7636Z2I) GREEN TEA LEAF (UNII: W2ZU1RY8B0) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) ETHYL BUTYRATE (UNII: UFD2LZ005D) BUTYL ISOVALERATE (UNII: 4UX6V9QM2J) .GAMMA.-DECALACTONE (UNII: 7HLS05KP9O) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-IONONE (UNII: I9V075M61R) 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:61649-723-01 120 g in 1 TUBE; Type 0: Not a Combination Product 05/15/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 05/15/2021 Labeler - Attitude DBA 9055-7588 Québec Inc. (201137051) Establishment Name Address ID/FEI Business Operations Attitude DBA 9055-7588 Québec Inc. 204307099 manufacture(61649-723) , label(61649-723) , pack(61649-723) , analysis(61649-723)
