Label: BIO SPECTRA ATTITUDE- sodium fluoride gel, dentifrice

  • NDC Code(s): 61649-734-01
  • Packager: 9055-7588 Québec Inc. DBA ATTITUDE
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 14, 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.

  • INACTIVE INGREDIENT

    Inactive ingredients / Ingrédients inactifs : Aqua / Water / Eau, Sorbitol, Glycerin, Hydrated Silica, Sodium Lauryl Sulfate, Gaultheria Procumbens (Wintergreen) Leaf Oil, Xanthan Gum, Citric Acid, Rebaudioside A, Sodium Benzoate, Sodium Bicarbonate, Potassium Sorbate, Carica Papaya (Papaya) Leaf Extract, Camellia Sinensis (Tea) Leaf Extract.

  • QUESTIONS?

    Questions? +1-855-509-7225

  • PRINCIPAL DISPLAY PANEL - 120 g Tube Label

    ATTITUDE ®

    natural care

    EWG Verified

    Vegan

    with fluoride

    toothpaste

    Spearmint
    ENAMEL CARE
    Super leaves TM

    NPN 80104880

    120 g / 4.2 OZ.

    Label

  • INGREDIENTS AND APPEARANCE
    BIO SPECTRA  ATTITUDE
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61649-734
    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)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    REBAUDIOSIDE A (UNII: B3FUD0528F)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CARICA PAPAYA LEAF (UNII: 66J7636Z2I)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Product Characteristics
    Colorwhite (Opaque) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61649-734-01120 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 DrugM02105/15/2021
    Labeler - 9055-7588 Québec Inc. DBA ATTITUDE (201137051)
    Establishment
    NameAddressID/FEIBusiness Operations
    9055-7588 Québec Inc. DBA ATTITUDE204307099manufacture(61649-734) , label(61649-734) , pack(61649-734) , analysis(61649-734)
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