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
  • 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 27, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • Active ingredients

    Potassium nitrate 5%

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

  • Purposes

    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:
    o
    apply at least a 1-inch strip of the product onto a soft bristle toothbrush.
    o
    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

    •
    do not store above 25°C (77°F)
  • Inactive ingredients

    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?

    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

    Repairs Weakened Enamel*

    For Strong, Healthy Teeth

    NET WT 3.4 OZ (96.4 g)

    SENSODYNEPRONAMEL

    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.

    Recycle Carton, Tube and Cap

    Save Water Turn off tap while brushing

    ALWAYS FOLLOW THE LABEL

    Trademarks owned or licensed by GSK. ©2022 GSK or licensor.

    Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

    62000000069608 Front Carton

    Sensodyne Pronamel Intensive Enamel Repair Clean Mint
  • Principal Display Panel

    NDC 0135-0486-01

    SENSODYNE

    PRONAMEL

    INTENSIVE ENAMEL REPAIR

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    EXTRA FRESH

    Repairs Weakened Enamel*

    For Strong, Healthy Teeth

    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.

    Recycle Carton, Tube and Cap

    Save Water Turn off tap while brushing

    ALWAYS FOLLOW THE LABEL

    Trademarks owned or licensed by GSK. ©2022 GSK or licensor.

    Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

    62000000068911 Front Carton

    Sensodyne Pronamel Intensive Enamel Repair Extra Fresh
  • Principal Display Panel

    NDC 0135-0481-01

    SENSODYNE

    PRONAMEL

    INTENSIVE ENAMEL REPAIR

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    WHITENING ARTIC BREEZE

    Repairs Weakened Enamel*

    For Strong, Healthy Teeth

    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

    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.

    Recycle Carton, Tube and Cap

    Save Water Turn off tap while brushing

    ALWAYS FOLLOW THE LABEL

    Trademarks owned or licensed by GSK. ©2022 GSK or licensor.

    Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

    62000000068993 Front Carton

    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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!