Label: BIO SPECTRA ATTITUDE- sodium fluoride gel, dentifrice

  • NDC Code(s): 61649-725-01
  • Packager: 9055-7588 Quebec Inc. DBA Attitude
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 2, 2024

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active ingredient

    Sodium fluoride (0.243% w/w)

  • Purpose

    Anti-cavity

  • Uses

    • Prevents, fights and protects against cavities and tooth decay.
    • Effective fluoride protection.
    • Protects teeth from acid erosion.
    • Penetrates tooth enamel to help rebuild weak spots.
  • Warnings

    Keep out of reach of children.

    If swallowed, call a poison control centre or get medical help right away.

  • 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, Rebaudioside A, Sodium Benzoate, Potassium Sorbate, Carica Papaya (Papaya) Leaf Extract, Camellia Sinensis (Tea) Leaf Extract, Hexyl Hexanoate*, L-Alpha-Pinene*, 3-Hexenol*, Caprylic/Capric Triglyceride*, Vanillin*, *Flavour (Aroma).

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  • PRINCIPAL DISPLAY PANEL - 120 g Tube Label

    ATTITUDE ®

    with fluoride

    toothpaste
    MANGO

    VEGAN

    Little leaves

    NPN 80104880

    120 g e 4.2 OZ.

    Label

  • INGREDIENTS AND APPEARANCE
    BIO SPECTRA  ATTITUDE
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61649-725
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.243 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    3-HEXEN-1-OL, (3Z)- (UNII: V14F8G75P4)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    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)  
    REBAUDIOSIDE A (UNII: B3FUD0528F)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CARICA PAPAYA LEAF (UNII: 66J7636Z2I)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    HEXYL HEXANOATE (UNII: GI6FE1QMW6)  
    VANILLIN (UNII: CHI530446X)  
    .ALPHA.-PINENE (UNII: JPF3YI7O34)  
    Product Characteristics
    Colorwhite (Opaque) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61649-725-01120 g in 1 TUBE; Type 0: Not a Combination Product02/05/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02102/05/2024
    Labeler - 9055-7588 Quebec Inc. DBA Attitude (201137051)
    Establishment
    NameAddressID/FEIBusiness Operations
    9055-7588 Quebec Inc. DBA Attitude204307099manufacture(61649-725) , label(61649-725) , pack(61649-725) , analysis(61649-725)
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