Label: SENSODYNE PRONAMEL GENTLE WHITENING ADVANCED- potassium nitrate and sodium fluoride paste

  • NDC Code(s): 0135-0580-01, 0135-0580-02
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated March 4, 2024

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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 of age: Consult a dentist or doctor.
  • Other information

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

    water, hydrated silica, sorbitol, glycerin, PEG-8, cocamidopropyl betaine, flavor, xanthan gum, titanium dioxide, sodium saccharin, sodium hydroxide

  • Questions or comments?

    1-866-844-2797

    Additional information

    ALWAYS FOLLOW THE LABEL

    SENSODYNE PRONAMEL

    Does not contain: SLS/sulfates • artificial dyes • parabens • triclosan • peroxide

    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.

    ©2021 GSK group of companies or its licensor.

    Distributed by:

    GSK Consumer Healthcare

    Warren, NJ 07059

  • Principal Display Panel

    NDC 0135-0580-01

    SENSODYNE

    PRONAMEL

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    GENTLE WHITENING

    ADVANCED

    Specialist Enamel Protection

    Rebuilds, Restores, Refreshes

    NET WT 6.5 OZ (184 g)

    62000000069596 Front Carton

    Sensodyne Gentle Whitening Advanced 6.5 OZ (184 g)
  • INGREDIENTS AND APPEARANCE
    SENSODYNE PRONAMEL  GENTLE WHITENING ADVANCED
    potassium nitrate and sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0580
    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)  
    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
    ColorWHITEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0580-011 in 1 CARTON03/15/2021
    1184 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-0580-024 in 1 CARTON07/01/2023
    2184 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02203/15/2021
    Labeler - Haleon US Holdings LLC (079944263)
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