Label: SENSODYNE- potassium nitrate and sodium fluoride paste
- NDC Code(s): 0135-0593-01, 0135-0593-02
- 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 November 15, 2021
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- Active ingredients
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.
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
- Inactive ingredients
- Questions or comments?
ALWAYS FOLLOW THE LABEL
What are sensitive teeth?
Lots of people have sensitive teeth. When enamel is worn away (through eating everyday acidic food or drinks) or gums recede, the dentin underneath becomes exposed. This can lead to tooth sensitivity, for example, with cold and hot food and drinks.
What does Sensodyne do?
Sensodyne provides daily care for sensitive teeth* plus all the benefits you would expect from a daily fluoride toothpaste – strong teeth and freshness.
*with twice daily brushing
24/7 Sensitivity Protection*
+ Strong & Healthy Teeth
Use Sensodyne Deep Clean + Whitening twice daily:
- Long lasting sensitivity protection* every day
- Contains fluoride to protect against cavities
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©2020 GSK group of companies or its licensor.
GSK Consumer Healthcare
Warren, NJ 07059
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INGREDIENTS AND APPEARANCE
potassium nitrate and sodium fluoride paste
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0593 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) SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SODIUM LAURYL SULFATE (UNII: 368GB5141J) XANTHAN GUM (UNII: TTV12P4NEE) SODIUM HYDROXIDE (UNII: 55X04QC32I) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SACCHARIN SODIUM (UNII: SB8ZUX40TY) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Product Characteristics Color BLUE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0593-01 1 in 1 CARTON 12/19/2016 1 113 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:0135-0593-02 1 in 1 CARTON 12/19/2016 07/31/2019 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 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)