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

    Potassium nitrate 5%

    Sodium fluoride 0.25% (0.16% 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

    •
    store below 30ºC (86ºF)
  • Inactive ingredients

    water, hydrated silica, sorbitol, glycerin, pentasodium triphosphate, PEG-8, sodium lauryl sulfate, flavor, xanthan gum, sodium hydroxide, cocamidopropyl betaine, sodium saccharin, blue 1

  • Questions or comments?

    1-866-844-2797

  • Additional Information

    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

    Exposed Dentin

    Use Sensodyne Deep Clean + Whitening twice daily:

    •
    Long lasting sensitivity protection* every day
    •
    Contains fluoride to protect against cavities

    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

  • Principal Display Panel

    NDC 0135-0593-01

    #1 DENTIST RECOMMENDED BRAND

    SENSODYNE

    Deep Clean + Whitening

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    24/7 Sensitivity Protection* + Strong & Healthy Teeth

    NET WT 4.0 OZ (113 g)

    62000000053546

    Sensodyne Deep Clean 4oz (113 g)
  • INGREDIENTS AND APPEARANCE
    SENSODYNE 
    potassium nitrate and sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0593
    Route of AdministrationDENTAL
    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)  
    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
    ColorBLUEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0593-011 in 1 CARTON12/19/2016
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-0593-021 in 1 CARTON12/19/201607/31/2019
    223 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 finalpart35612/19/2016
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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