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
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
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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
- Inactive ingredients
- Questions or comments?
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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
-
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
-
INGREDIENTS AND APPEARANCE
SENSODYNE PRONAMEL STRONG AND BRIGHT ENAMEL MINT
potassium nitrate and sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0602 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) 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 Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0602-01 1 in 1 CARTON 12/19/2016 1 85 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:0135-0602-02 1 in 1 CARTON 12/19/2016 2 23 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 12/19/2016 SENSODYNE PRONAMEL STRONG AND BRIGHT ENAMEL EXTRA FRESH
potassium nitrate and sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0603 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) 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 Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0603-01 1 in 1 CARTON 12/19/2016 1 85 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 12/19/2016 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)