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
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purposes
- Uses
- Warnings
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Directions
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adults and children 12 years of age and older:
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- apply at least a 1-inch strip of the product onto a soft bristle toothbrush.
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- 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.
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- children under 12 years of age: Consult a dentist or doctor.
- Other information
- Inactive ingredients
- Questions or comments?
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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
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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
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INGREDIENTS AND APPEARANCE
SENSODYNE PRONAMEL ACTIVE SHIELD FRESH MINT
potassium nitrate and sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0700 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 50 mg in 1 g SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.15 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Shape Size Flavor MINT (Fresh Mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0700-01 1 in 1 CARTON 01/02/2023 1 96.4 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:0135-0700-02 23 g in 1 TUBE; Type 0: Not a Combination Product 01/02/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 01/02/2023 SENSODYNE PRONAMEL ACTIVE SHIELD COOL MINT
potassium nitrate and sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0701 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 50 mg in 1 g SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.15 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Shape Size Flavor MINT (Cool Mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0701-01 1 in 1 CARTON 01/02/2023 1 96.4 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:0135-0701-02 1 in 1 CARTON 01/02/2023 2 65.2 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 01/02/2023 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) (079944263)