Label: SENSODYNE PRONAMEL ACTIVE SHIELD FRESH MINT- potassium nitrate and sodium fluoride paste
SENSODYNE PRONAMEL ACTIVE SHIELD COOL MINT- potassium nitrate and sodium fluoride paste

  • NDC Code(s): 0135-0700-01, 0135-0700-02, 0135-0701-01, 0135-0701-02
  • 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 August 17, 2022

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  • Active ingredient

    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

    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

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

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

  • Questions or comments?

    1-866-844-2797

  • Additional information (Fresh Mint)

    SENSODYNE PRONAMEL ACTIVE SHIELD

    No 1 dentist recommended brand for enamel protection & strengthening.

    Enamel is your natural defense shield for healthy teeth. Everyday it can be weakened by dietary or sugar acids which make your teeth more at risk to cavities and enamel wear.

    New Pronamel Active Shield – start building resistance today to help keep your teeth strong and healthy for life.**

    Acids from foods, drinks or sugars weaken the enamel surface

    Pronamel has a proven formula that actively reinforces weakened enamel

    Proven toactively reinforce weakened enamel

    Developed for defense against cavities and enamel wear by remineralizing your weakened enamel. Pronamel Active Shield helps with:

    2X stronger resistance against dietary acids from Day 1*

    Helps shield the enamel against erosion and cavities

    Enhanced foaming action# with extra fresh mint to leave the whole mouth feeling clean and fresh

    *vs your mouth’s natural defenses

    ** With continued twice daily brushing, a healthy diet and regular dental visits.

    #vs Pronamel Daily Protection

    ALWAYS FOLLOW THE LABEL

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

    Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

  • Additional information (Cool Mint)

    SENSODYNE PRONAMEL ACTIVE SHIELD

    No 1 dentist recommended brand for enamel protection & strengthening.

    Enamel is your natural defense shield for healthy teeth. Everyday it can be weakened by dietary or sugar acids which make your teeth more at risk to cavities and enamel wear.

    New Pronamel Active Shield – start building resistance today to help keep your teeth strong and healthy for life.**

    Acids from foods, drinks or sugars weaken the enamel surface

    Pronamel has a proven formula that actively reinforces weakened enamel

    Proven toactively reinforce weakened enamel

    Developed for defense against cavities and enamel wear by remineralizing your weakened enamel. Pronamel Active Shield helps with:

    2X stronger resistance against dietary acids from Day 1*

    Helps shield the enamel against erosion and cavities

    Enhanced foaming action# with extra fresh mint to leave the whole mouth feeling clean and fresh

    Effectively and gently removes stains for whiter teeth

    *vs your mouth’s natural defenses

    ** With continued twice daily brushing, a healthy diet and regular dental visits.

    #vs Pronamel Daily Protection

    ALWAYS FOLLOW THE LABEL

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

    Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

  • Principal Display Panel

    SENSODYNE

    PRONAMEL ACTIVE SHIELD

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    FRESH MINT

    Builds Enamel Resistance

    For Cavity & Erosion Protection

    NET WT 3.4 OZ (96.4 g)

    62000000200006 – Front Carton

    Sensodyne Pronamel Active Shield FM 3.4oz_Carton
  • Principal Display Panel

    SENSODYNE

    PRONAMEL

    ACTIVE SHIELD

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    COOL MINT WHITENING

    Builds Enamel Resistance

    For Cavity & Erosion Protection

    NET WT 3.4 OZ (96.4 g)

    620000000200004 – Front Carton

    Sensodyne Pronamel Active Shield CM 3.4oz_Carton
  • INGREDIENTS AND APPEARANCE
    SENSODYNE PRONAMEL  ACTIVE SHIELD FRESH MINT
    potassium nitrate and sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0700
    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)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (Fresh Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0700-011 in 1 CARTON01/02/2023
    196.4 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-0700-0223 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 finalpart35601/02/2023
    SENSODYNE PRONAMEL  ACTIVE SHIELD COOL MINT
    potassium nitrate and sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0701
    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)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (Cool Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0701-011 in 1 CARTON01/02/2023
    196.4 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-0701-021 in 1 CARTON01/02/2023
    265.2 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 finalpart35601/02/2023
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) (079944263)
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