Label: SENSODYNE PRONAMEL GENTLE WHITENING ADVANCED- potassium nitrate and sodium fluoride paste
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- NDC Code(s): 0135-0580-01
- 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 9, 2020
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- Active ingredients
- 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
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Questions or comments?
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Additional information
ALWAYS FOLLOW THE LABEL
SENSODYNE PRONAMEL
Acidic foods and drinks can cause enamel loss that can lead to yellowing, dullness and sensitivity. Pronamel has a specialty formulation to help rebuild and restore acid weakened enamel, helping prevent enamel loss for strong, healthy teeth.
ACID ATTACKS ENAMEL
WEAKENING THE ENAMEL STRUCTURE
PRONAMEL REBUILDS & RESTORES ENAMEL
FOR STRONG HEALTHY TEETH
Healthy white teeth start with strong enamel.
Pronamel has a proven specialist technology that has been developed to maximize the effect of fluoride on enamel.
With twice-daily brushing, Pronamel helps to:
• Rebuild enamel strength for strong, healthy teeth
• Protect against the effects of dietary acids
• Relieve sensitive teeth
• Freshen breath
• Protect against cavities
Recyclable Carton Save Water
Turn off tap while brushing
Trademarks are owned by or licensed to the GSK group of companies.
©2020 GSK group of companies or its licensor.
Distributed by:
GSK Consumer Healthcare
Warren, NJ 07059
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INGREDIENTS AND APPEARANCE
SENSODYNE PRONAMEL GENTLE WHITENING ADVANCED
potassium nitrate and sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0580 Route of Administration DENTAL 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) XANTHAN GUM (UNII: TTV12P4NEE) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM HYDROXIDE (UNII: 55X04QC32I) Product Characteristics Color WHITE Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0580-01 1 in 1 CARTON 03/15/2021 1 184 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 03/15/2021 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
