Label: SENSODYNE PRONAMEL INTENSIVE ENAMEL REPAIR CLEAN MINT- potassium nitrate and sodium fluoride paste
SENSODYNE PRONAMEL INTENSIVE ENAMEL REPAIR EXTRA FRESH- potassium nitrate and sodium fluoride paste
SENSODYNE PRONAMEL INTENSIVE ENAMEL REPAIR WHITENING- potassium nitrate and sodium fluoride paste

  • NDC Code(s): 0135-0481-01, 0135-0481-02, 0135-0486-01, 0135-0486-02, view more
    0135-0492-01, 0135-0492-02, 0135-0492-03
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US)
  • Category: HUMAN OTC DRUG LABEL

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 September 6, 2022

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active ingredient

    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 of age: Consult a dentist or doctor.
  • Other information (Clean Mint, Extra Fresh)

    store below 25°C (77°F)

  • Inactive ingredients (Clean Mint)

    water, sorbitol, hydrated silica, glycerin, PEG-8, sodium lactate, flavor, cocamidopropyl betaine, titanium dioxide, xanthan gum, sodium saccharin, PVM/MA copolymer, sodium hydroxide

  • Inactive ingredients (Extra Fresh)

    water, sorbitol, hydrated silica, glycerin, PEG-8, sodium lactate, flavor, cocamidopropyl betaine, titanium dioxide, xanthan gum, sodium saccharin, PVM/MA copolymer, sodium hydroxide

  • Inactive Ingredients (Whitening)

    water, sorbitol, hydrated silica, glycerin, PEG-8, sodium lactate, flavor, cocamidopropyl betaine, titanium dioxide, xanthan gum, sodium saccharin, PVM/MA copolymer, sodium hydroxide

  • Questions or comments?

    Call toll-free 1-866-844-2797

  • Principal Display Panel

    NDC 0135-0492-01

    SENSODYNE

    PRONAMEL

    INTENSIVE ENAMEL REPAIR

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    CLEAN MINT

    ACTIVELY REPAIRS WEAKENED ENAMEL*

    NET WT 3.4 OZ (96.4 g)

    SENSODYNE

    PRONAMEL

    INTENSIVE ENAMEL REPAIR

    *Sensodyne Pronamel Intensive Enamel Repair is proven to drive minerals deep into the enamel surface to help actively repair acid-weakened areas of the enamel, for stronger, better-protected teeth.

    PRONAMEL ACTIVELY REPAIRS WEAKENED ENAMEL

    LOCKS IN MINERALS

    FOR STRONG HEALTHY TEETH

    Acids in modern diets can weaken your enamel surface. Over time, this can lead to your enamel thinning, allowing the yellow dull dentin layer underneath to show through. Once your enamel surface is weakened it needs extra care for the future.

    With twice-daily brushing, Sensodyne Pronamel Intensive Enamel Repair helps to:

    Actively repair acid-weakened enamel
    Lock in minerals to protect against the effects of acid wear
    Protect against cavities

    Sensodyne Pronamel Intensive Enamel Repair is suitable for sensitive teeth.

    ALWAYS FOLLOW THE LABEL

    Trademarks owned or licensed by GSK.

    ©2018 GSK or licensor.

    Distributed by:

    GSK Consumer Healthcare

    Warren, NJ 07059

    62000000030303

    Sensodyne Pronamel\62000000030303_Sensodyne Pronamel Intensive Enamel Clean Mint_3.4 OZ.JPG
  • Principal Display Panel

    NDC 0135-0486-01

    SENSODYNE

    PRONAMEL

    INTENSIVE ENAMEL REPAIR

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    EXTRA FRESH

    ACTIVELY REPAIRS WEAKENED ENAMEL*

    NET WT 3.4 OZ (96.4 g)

    SENSODYNE

    PRONAMEL

    INTENSIVE ENAMEL REPAIR

    *Sensodyne Pronamel Intensive Enamel Repair is proven to drive minerals deep into the enamel surface to help actively repair acid-weakened areas of the enamel, for stronger, better-protected teeth.

    PRONAMEL ACTIVELY REPAIRS WEAKENED ENAMEL

    LOCKS IN MINERALS

    FOR STRONG HEALTHY TEETH

    Acids in modern diets can weaken your enamel surface. Over time, this can lead to your enamel thinning, allowing the yellow dull dentin layer underneath to show through. Once your enamel surface is weakened it needs extra care for the future.

    With twice-daily brushing, Sensodyne Pronamel Intensive Enamel Repair helps to:

    Actively repair acid-weakened enamel
    Lock in minerals to protect against the effects of acid wear
    Protect against cavities

    Sensodyne Pronamel Intensive Enamel Repair is suitable for sensitive teeth.

    ALWAYS FOLLOW THE LABEL

    Trademarks owned or licensed by GSK.

    ©2018 GSK or licensor.

    Distributed by:

    GSK Consumer Healthcare

    Warren, NJ 07059

    62000000030306

    Sensodyne Pronamel\62000000030306_Sensodyne Pronamel Intensive Enamel Extra Fresh_3.4 OZ.JPG
  • Principal Display Panel

    NDC 0135-0481-01

    New

    SENSODYNE

    PRONAMEL

    INTENSIVE ENAMEL REPAIR

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    WHITENING

    ACTIVELY REPAIRS WEAKENED ENAMEL*

    NET WT 3.4 OZ (96.4 g)

    SENSODYNE

    PRONAMEL

    INTENSIVE ENAMEL REPAIR

    WHITENING

    *Sensodyne Pronamel Intensive Enamel Repair is proven to drive minerals deep into the enamel surface to help actively repair acid-weakened areas of the enamel, for stronger, better-protected teeth.

    PRONAMEL ACTIVELY REPAIRS WEAKENED ENAMEL

    LOCKS IN MINERALS

    FOR STRONG HEALTHY TEETH

    Actively repairs enamel weakened by dietary acids and helps whiten teeth

    With twice-daily brushing, Sensodyne Pronamel Intensive Enamel Repair Whitening helps to:

    Lock in minerals to protect against the effects of acid wear
    Protect against cavities
    Effectively removes stains to whiten teeth
    Restore natural whiteness of teeth

    Sensodyne Pronamel Intensive Enamel Repair is suitable for sensitive teeth.

    ALWAYS FOLLOW THE LABEL

    Trademarks owned or licensed to the GSK group of companies.

    ©2019 GSK group of companies or licensor.

    Distributed by:

    GSK Consumer Healthcare

    Warren, NJ 07059

    620000000371915

    Sensodyne Pronamel Intensive Enamel Repair Whitening
  • INGREDIENTS AND APPEARANCE
    SENSODYNE PRONAMEL  INTENSIVE ENAMEL REPAIR CLEAN MINT
    potassium nitrate and sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0492
    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)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINT (Clean Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0492-011 in 1 CARTON11/29/2018
    196.4 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-0492-021 in 1 CARTON11/29/2018
    223 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:0135-0492-0323 g in 1 TUBE; Type 0: Not a Combination Product01/02/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35611/29/2018
    SENSODYNE PRONAMEL  INTENSIVE ENAMEL REPAIR EXTRA FRESH
    potassium nitrate and sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0486
    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)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINT (Extra Fresh) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0486-011 in 1 CARTON11/29/2018
    196.4 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-0486-022 in 1 CARTON01/06/2020
    296.4 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 finalpart35611/29/2018
    SENSODYNE PRONAMEL  INTENSIVE ENAMEL REPAIR WHITENING
    potassium nitrate and sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0481
    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)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINT (Arctic Breeze) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0481-011 in 1 CARTON01/06/2020
    196.4 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-0481-022 in 1 CARTON01/06/2020
    296.4 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 finalpart35601/06/2020
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) (079944263)
    Establishment
    NameAddressID/FEIBusiness Operations
    BERNARDY263254254API MANUFACTURE(0135-0492, 0135-0486, 0135-0481)