Label: SENSODYNE RAPID RELIEF- stannous fluoride paste

  • NDC Code(s): 0135-0621-01, 0135-0621-02, 0135-0622-01, 0135-0632-01
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 6, 2024

If you are a consumer or patient please visit this version.

  • Active ingredient

    Stannous fluoride 0.454% (0.15% w/v fluoride ion)

  • Purposes

    Anticavity

    Antihypersensitivity

  • Uses

    • aids in the prevention of dental cavities.
    • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact.
  • 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

    • products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
    • this product is specifically formulated to help prevent staining
    • do not store above 30°C (86°F)
  • Inactive ingredients (Extra Fresh)

    glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin

  • Inactive ingredients (Mint)

    glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, sodium saccharin, cocamidopropyl betaine

  • Inactive Ingredients (Whitening)

    glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, sodium saccharin, cocamidopropyl betaine

  • Questions or comments?

    1-866-844-2797

  • Additional Information

    ALWAYS FOLLOW THE LABEL

    SENSODYNE RAPIDRELIEF

    What is tooth sensitivity?

    Sensitivity occurs when the dentin underneath tooth enamel becomes exposed. When exposed dentin comes into contact with hot or cold, sweet or sour, or even your toothbrush, it can trigger the nerve causing a short, sharp pain.

    CAUSE OF SENSITIVITY PAIN

    TINY HOLES IN DENTIN

    FAST ACTING FORMULA

    QUICKLY CREATES A BARRIER

    FAST RELIEF FROM PAIN*

    Fast RELIEF* and Long lasting Protection**

    Sensodyne Rapid Relief is clinically proven for fast relief of sensitivity pain.

    Its formula quickly creates a barrier over sensitive areas of your teeth to provide fast relief, and to help stop the pain from coming back. With twice daily brushing, it builds ongoing protection from the pain of sensitive teeth. It also helps whiten enamel and prevents staining.

    *significant pain relief in 3 days

    **with twice daily brushing

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

    ©2023 Haleon group of companies or its licensor.

    Distributed by: Haleon, Warren, NJ 07059

    Pat. Info www.productpats.com

  • Principal Display Panel

    #1 DENTIST RECOMMENDED BRAND

    SENSODYNE

    FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH

    AND CAVITY PREVENTION

    EXTRA FRESH

    RAPID RELIEF

    & LONG LASTING PROTECTION**

    NET WT 3.4 OZ (96.4 g)

    62000000207034

    Sensodyne Rapid Relief Extra Fresh 96g
  • Principal Display Panel

    #1 DENTIST RECOMMENDED BRAND

    SENSODYNE

    FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH

    AND CAVITY PREVENTION

    MINT

    RAPID RELIEF

    & LONG LASTING PROTECTION**

    NET WT 3.4 OZ (96.4 g)

    62000000207014

    Sensodyne Rapid Relief Mint 96g
  • Principal Display Panel

    NDC 0135-0632-01

    #1 DENTIST RECOMMENDED BRAND

    SENSODYNE

    FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH

    AND CAVITY PREVENTION

    WHITENING

    RAPID RELIEF

    & LONG LASTING PROTECTION**

    NET WT 3.4 OZ (96.4 g)

    62000000057071 Carton

    Sensodyne Rapid Relief Whitening 3.4 oz (96.4 g)
  • INGREDIENTS AND APPEARANCE
    SENSODYNE   RAPID RELIEF
    stannous fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0622
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINT (Extra Fresh) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0622-011 in 1 CARTON01/08/2018
    196.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02201/08/2018
    SENSODYNE   RAPID RELIEF
    stannous fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0621
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0621-011 in 1 CARTON01/08/2018
    196.4 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-0621-021 in 1 CARTON01/08/2018
    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 DrugM02201/08/2018
    SENSODYNE   RAPID RELIEF
    stannous fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0632
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0632-011 in 1 CARTON07/08/2019
    196.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02207/08/2019
    Labeler - Haleon US Holdings LLC (079944263)