Label: SENSODYNE NOURISH HEALTHY WHITE- potassium nitrate and sodium fluoride paste

  • NDC Code(s): 0135-5027-01, 0135-5027-02
  • 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 September 30, 2021

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  • Active ingredients

    Potassium nitrate 5%

    Sodium fluoride 0.25% (0.15% 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: Consult a dentist or doctor.
  • Other information

    •
    do not store above 25°C (77°F)
  • Inactive ingredients

    water, sorbitol, hydrated silica, glycerin, sodium lauryl sulfate, flavor, xanthan gum, cocamidopropyl betaine, sodium saccharin, titanium dioxide

  • Questions or comments?

    1-866-844-2797

  • Additional Information

    ALWAYS FOLLOW THE LABEL

    SENSODYNE nourish

    WITH BIO-ACTIVE MINERALS

    •
    Brush twice daily for a healthier smile:
    •
    Strengthens & nourishes teeth
    •
    Effective & gentle whitening
    •
    Helps prevent cavities
    •
    Protects from sensitivity*
    •
    Freshens breath

    The Sensodyne Nourish range with bio-active minerals, strengthens and nourishes teeth while also protecting from sensitivity*. Our toothpaste is designed to provide the everyday nourishment your teeth to help protect the health of your mouth.

    Healthy White: With trusted sensitivity protection*, our formulation, blended with natural mint and citrus oil, provides a fresh, cleansing sensation.

    *with twice daily brush

    Help us support the planet by recycling our packaging and being responsible with water usage.

    Carton

    Recycle

    Tube

    Recycle

    Lot

    See end of carton

    Save Water

    Turn off tap whilst brushing

    Trademarks are owned by or licensed to the GSK group of companies.

    ©2021 GSK group of companies or its licensor.

    Distributed by:

    GSK Consumer Healthcare

    Warren, NJ 07059

  • Principal Display Panel

    NDC 0135-5027-01

    NEW

    SENSODYNE

    nourish

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    NOURISH & STRENGTHEN TEETH FOR A HEALTHY MOUTH

    healthy white

    natural mint & citrus oil

    WITH BIO-ACTIVE MINERALS

    NET WT 4.0 OZ (113 g)

    62000000064837 Front Carton

    Sensodyne Nourish Healthy 4.0oz (113g) carton
  • INGREDIENTS AND APPEARANCE
    SENSODYNE  NOURISH HEALTHY WHITE
    potassium nitrate and sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-5027
    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)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-5027-011 in 1 CARTON01/03/2022
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-5027-021 in 1 CARTON01/03/2022
    277 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 finalpart35601/03/2022
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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