Label: SENSODYNE PRONAMEL STRONG AND BRIGHT ENAMEL MINT- potassium nitrate and sodium fluoride paste
SENSODYNE PRONAMEL STRONG AND BRIGHT ENAMEL EXTRA FRESH- potassium nitrate and sodium fluoride paste

  • NDC Code(s): 0135-0602-01, 0135-0602-02, 0135-0603-01
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • 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 December 14, 2020

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  • Active ingredients

    Potassium nitrate 5%

    Sodium fluoride 0.25% (0.15% w/v fluoride ion)

  • Purpose

    Antihypersensitivity

    Anticavity

  • Uses

    •
    builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
    •
    aids in the prevention of dental cavities.
  • Warnings

    When using this product,

    if irritation occurs discontinue use.

    Stop use and ask a dentist if

    •
    the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
    •
    pain/sensitivity still persists after 4 weeks of use.

    Keep out of reach of children.

    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 12 years of age and older:

    Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.

    Children under 12 years

    Consult a dentist or doctor.
  • Other information

    store below 25°C (77°F)

  • Inactive ingredients

    water, hydrated silica, sorbitol, glycerin, PEG-8, flavor, cocamidopropyl betaine, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide

  • Questions or comments?

    Call toll-free 1-866-844-2797

  • Principal Display Panel

    NDC 0135-0602-01

    SENSODYNE

    PRONAMEL

    STRONG & Bright

    ENAMEL

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    STRONG ENAMEL

    WHITER TEETH*

    MINT

    No. 1 DENTIST RECOMMENDED BRAND

    FOR STRENGTHENING AND PROTECTING ENAMEL

    *vs. ProNamel Daily Protection

    NET WT 3.0 OZ (85 g)

    Enamel is the vital layer of protection for your teeth and keeping it strong is so important.

    Sensodyne ProNamel STRONG & Bright ENAMEL gives you whiter teeth* while actively helping to strengthen your tooth enamel and protect against everyday acids.

    *vs. ProNamel Daily Protection

    With twice daily brushing, the dual action formulation:

    •
    Delivers minerals into the enamel to help STRENGTHEN & PROTECT.
    •
    Polishes away stains for WHITER BRIGHTER TEETH.

    FRESHENS breath and fights CAVITIES

    GSK Consumer Healthcare

    Warren, NJ 07059

    Trademarks are owned by or licensed to the GSK group of companies.

    ©2017 GSK group of companies or its licensor

    ALWAYS FOLLOW THE LABEL

    105491XC105491XC_ProNamel Strong & Bright_3.0 oz.JPG

  • Principal Display Panel

    NDC 0135-0603-01

    SENSODYNE

    PRONAMEL

    STRONG & Bright

    ENAMEL

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    STRONG ENAMEL

    WHITER TEETH*

    EXTRA FRESH

    No. 1 DENTIST RECOMMENDED BRAND

    FOR STRENGTHENING AND PROTECTING ENAMEL

    *vs. ProNamel Daily Protection

    NET WT 3.0 OZ (85 g)

    Enamel is the vital layer of protection for your teeth and keeping it strong is so important.

    Sensodyne ProNamelSTRONG & Bright ENAMEL gives you whiter teeth* while actively helping to strengthen your tooth enamel and protect against everyday acids.

    *vs. ProNamel Daily Protection

    With twice daily brushing, the dual action formulation:

    •
    Delivers minerals into the enamel to help STRENGTHEN & PROTECT.
    •
    Polishes away stains for WHITER BRIGHTER TEETH.

    FRESHENS breath and fights CAVITIES

    GSK Consumer Healthcare

    Warren, NJ 07059

    Trademarks are owned by or licensed to the GSK group of companies.

    ©2017 GSK group of companies or its licensor.

    ALWAYS FOLLOW THE LABEL

    105488XC

    105488XC_ProNamel Strong and Bright Enamel Extra Fresh_3 oz.JPG
  • INGREDIENTS AND APPEARANCE
    SENSODYNE PRONAMEL  STRONG AND BRIGHT ENAMEL MINT
    potassium nitrate and sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0602
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE50 mg  in 1 g
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.15 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0602-011 in 1 CARTON12/19/2016
    185 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-0602-021 in 1 CARTON12/19/2016
    223 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35612/19/2016
    SENSODYNE PRONAMEL  STRONG AND BRIGHT ENAMEL EXTRA FRESH
    potassium nitrate and sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0603
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE50 mg  in 1 g
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.15 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0603-011 in 1 CARTON12/19/2016
    185 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35612/19/2016
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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