Label: ATTITUDE ADULT FLUORIDE-FREE - SENSITIVE - SPEARMINT- potassium nitrate gel, dentifrice

  • NDC Code(s): 61649-743-01
  • Packager: Attitude DBA 9055-7588 Québec Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 July 10, 2023

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Medicinal ingredient

    Potassium nitrate (5% w/w)

  • Purpose

    Anti-hypersensitivity

  • Uses

    • Builds protection against sensitivity of the teeth.
    • Shields and soothes dental nerves for lasting sensitivity relief when used regularly.
  • Warnings

    Keep out of reach of children.

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

  • STOP USE

    Sensitive teeth may indicate a serious problem. Stop use and consult a health care professional ifsymptoms persist or worsen.

  • 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).

  • Non-medicinal ingredients

    Sorbitol, aqua, glycerin, hydrated silica, sodium methyl cocoyl taurate, gaultheria procumbens (wintergreen) leaf oil 1, xanthan gum, citric acid, stevia rebaudiana leaf/stem extract, sodium benzoate, carica papaya (papaya) leaf extract, camellia sinensis (green tea) leaf extract, potassium sorbate, sodium chloride.

    1
    Naturally contains : D-limonene.
  • QUESTIONS?

    +1 (514) 509-7225

  • PRINCIPAL DISPLAY PANEL - 120 g Tube Label

    ATTITUDE ®
    bio spectra
    natural care

    toothpaste • fluoride free

    toothpaste
    SENSITIVE
    Spearmint • Fluoride free

    ECO-CONSCIOUS

    • EWG VERIFIED •
    FOR YOUR HEALTH • EWG.ORG

    VEGAN

    NPN 80109941

    GEL • 120 g e 4.2 OZ.

    PRINCIPAL DISPLAY PANEL - 120 g Tube Label
  • INGREDIENTS AND APPEARANCE
    ATTITUDE ADULT FLUORIDE-FREE - SENSITIVE - SPEARMINT 
    potassium nitrate gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61649-743
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CARICA PAPAYA LEAF (UNII: 66J7636Z2I)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Product Characteristics
    Colorwhite (Opaque) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61649-743-01120 g in 1 TUBE; Type 0: Not a Combination Product06/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35606/01/2022
    Labeler - Attitude DBA 9055-7588 Québec Inc. (201137051)
    Establishment
    NameAddressID/FEIBusiness Operations
    Attitude DBA 9055-7588 Québec Inc.204307099manufacture(61649-743) , label(61649-743) , pack(61649-743) , analysis(61649-743)
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