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 June 2, 2022

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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

    Sorbitol, aqua, glycerin, hydrated silica, sodium lauryl sulfate, xanthan gum, citric acid, stevia rebaudiana leaf / stem extract, sodium benzoate, carica papaya leaf extract, camellia sinensis (green tea) leaf extract, titanium dioxide, potassium sorbate, ethyl butyrate (fruit), butyl isovalerate (fruit), gamma decalactone (fruit).

  • QUESTIONS?

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  • PRINCIPAL DISPLAY PANEL - 120 g Tube Label

    ATTITUDE®
    bio spectra
    natural care

    for kids • with fluoride

    toothpaste
    BLUEBERRY
    Prevents cavities

    VEGAN

    NPN 80104880
    GEL • 120 g e 4.2 OZ.

    Principal Display Panel - 120 g Tube Label
  • INGREDIENTS AND APPEARANCE
    BIO SPECTRA   ATTITUDE
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61649-723
    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
    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)  
    Titanium dioxide (UNII: 15FIX9V2JP)  
    Potassium sorbate (UNII: 1VPU26JZZ4)  
    Ethyl butyrate (UNII: UFD2LZ005D)  
    Butyl isovalerate (UNII: 4UX6V9QM2J)  
    .Gamma.-Decalactone (UNII: 7HLS05KP9O)  
    Product Characteristics
    ColorWHITE (Opaque) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61649-723-01120 g in 1 TUBE; Type 0: Not a Combination Product05/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35505/15/2021
    Labeler - Attitude DBA 9055-7588 Québec Inc. (201137051)
    Establishment
    NameAddressID/FEIBusiness Operations
    Attitude DBA 9055-7588 Québec Inc.204307099MANUFACTURE(61649-723) , LABEL(61649-723) , PACK(61649-723) , ANALYSIS(61649-723)
    Establishment
    NameAddressID/FEIBusiness Operations
    Attitude DBA 9055-7588 Québec Inc.201137051MANUFACTURE(61649-723) , ANALYSIS(61649-723)