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 September 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

  • Generic Section

    SENSODYNE PRONAMEL

    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.

    ACID ATTACKS ENAMEL

    WEAKENING THE ENAMEL STRUCTURE

    PRONAMEL REBUUILDS & RESTORES ENAMEL

    FOR STRONG HEALTHY TEETH

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

    * removes stains

    ALWAYS FOLLOW THE LABEL

    CARTON RECYCLE

    TUBE RECYCLE

    CAP† CHECK LOCALLY

    † Recycling facilities for the cap may not exist in your area

    Save Water

    Turn off tap while brushing

    Recyclable Packaging

    Recyclable Carton

    Recyclable Tube & Cap†

    SPECIALIST ENAMEL PROTECTION

    The acids in your diet can damage tooth enamel, leading to dull, yellow teeth.

    Wine Acids

    Fruit Acids

    Soda Acids

    Pronamel strengthens acid weakened enamel and protects teeth from these acids, keeping teeth strong, healthy and white.

    SENSODYNE PRONAMEL

    POWERFUL WHITENING*

    GENTLE ON ENAMEL

    #1 DENTIST RECOMMENDED ENAMEL BRAND

  • Principal Display Panel

    4 PACK

    SENSODYNE PRONAMEL

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    Specialist Enamel Protection

    Rebuilds, Restores, Refreshes

    Alpine Breeze

    GENTLE WHITENING

    ADVANCED

    POWERFUL WHITENING*,

    GENTLE ON ENAMEL

    4 TUBES OF 6.5 OZ (184 g) EACH – TOTAL NET WT 26 OZ (736 g)

    Sensodyne Pronamel GW Adv 4 pk
  • 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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