Label: SENSODYNE SENSITIVITY AND GUM MINT- stannous fluoride paste
SENSODYNE SENSITIVITY AND GUM WHITENING- stannous fluoride paste
SENSODYNE SENSITIVITY AND GUM CLEAN AND FRESH- stannous fluoride paste

  • NDC Code(s): 0135-5023-01, 0135-5023-02, 0135-5023-03, 0135-5023-04, view more
    0135-5024-01, 0135-5024-02, 0135-5025-01
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 7, 2024

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

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  • Active ingredient

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

  • Purposes

    Anticavity, Antigingivitis, Antihypersensitivity

  • Uses

    • aids in the prevention of dental cavities.
    • helps control bleeding gums.
    • helps interfere with harmful effects of plaque associated with gingivitis.
    • 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.
    • gingivitis, bleeding, or redness persists for more than 2 weeks.
    • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These maybe signs or symptoms of periodontitis, a serious form of gum disease.

    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 (Sensitivity & Gum Whitening)

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

  • Inactive ingredients (Sensitivity & Gum Mint)

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

  • Inactive ingredients (Clean & Fresh)

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

  • Questions or comments?

    1-866-844-2797

  • Additional Information (Whitening)

    ALWAYS FOLLOW THE LABEL

    Dual Action for TOOTH SENSITIVITY & GUM PROBLEMS

    SENSITIVE AREAS AND SWOLLEN, BLEEDING GUMS

    BUILDS A PROTECTIVE LAYER OVER SENSITIVE AREAS

    TARGETS AND HELPS REMOVE PLAQUE BACTERIA

    RELIEVES TOOTH SENSITIVITY* AND IMPROVES GUM HEALTH

    Why use Sensodyne Sensitivity & Gum?

    Sensodyne Sensitivity & Gum contains a clinically proven ingredient to relieve tooth sensitivity and improve gum health. It builds a protective layer over sensitive areas, effectively relieving tooth sensitivity. It targets and removes plaque bacteria associated with gingivitis, to help reduce swollen, bleeding gums. You can deal with both these concerning problems with one specialist toothpaste. Sensodyne Sensitivity & Gum is a daily fluoride toothpaste.

    *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

    †Recycling facilities for this product may not exist in your area

    CARTONRECYCLE

    TUBERECYCLE

    CAPCHECK LOCALLY†

  • Additional Information (Mint and Clean & Fresh)

    SENSODYNE

    SENSITIVITY & GUM

    Tooth sensitivity & gum problems?

    Many people with sensitive teeth also have gum problems. Tooth sensitivity can occur when exposed dentin comes into contact with cold, hot, sweet and sour. Early gum problems are caused by a build-up of plaque bacteria, which can lead to redness, swelling, and bleeding.

    SENSITIVE AREAS AND SWOLLEN, BLEEDING GUMS

    BUILDS A PROTECTIVE LAYER OVER SENSITIVE AREAS

    TARGETS AND HELPS REMOVE PLAQUE BACTERIA

    RELIEVES TOOTH SENSITIVITY* AND IMPROVES GUM HEALTH

    Dual Action for TOOTH SENSITIVITY & GUM PROBLEMS

    *with twice daily brushing

    Why use Sensodyne Sensitivity & Gum?

    Sensodyne Sensitivity & Gum contains a clinically proven ingredient to relieve tooth sensitivity and improve gum health. It builds a protective layer over sensitive areas, effectively relieving tooth sensitivity. It targets and removes plaque bacteria associated with gingivitis, to help reduce swollen, bleeding gums. You can deal with both these concerning problems with one specialist toothpaste. Sensodyne Sensitivity & Gum is a daily fluoride toothpaste.

    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

    †Recycling facilities for this product may not exist in your area

    CARTONRECYCLE

    TUBERECYCLE

    CAPCHECK LOCALLY†

  • Principal Display Panel (Whitening)

    #1 DENTIST RECOMMENDED BRAND

    SENSODYNE

    FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH, ANTIGINGIVITIS AND CAVITY PROTECTION

    WHITENING

    SENSITIVITY & GUM

    IMPROVES GUM HEALTH

    NET WT 2.3 OZ (65.2 g)

    62000000207518

    Sensodyne Sensitivity Gum Whitening 65g
  • Principal Display Panel (Mint)

    #1 DENTIST RECOMMENDED BRAND

    SENSODYNE

    FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH, ANTIGINGIVITIS AND CAVITY PROTECTION

    MINT

    SENSITIVITY & GUM

    IMPROVES GUM HEALTH

    NET WT 3.4 OZ (96.4 g)

    62000000207515

    Sensodyne Sensitivity Gum Mint 96g
  • Principal Display Panel (Clean & Fresh)

    #1 DENTIST RECOMMENDED BRAND

    SENSODYNE

    FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH, ANTIGINGIVITIS AND CAVITY PROTECTION

    CLEAN & FRESH

    SENSITIVITY & GUM

    IMPROVES GUM HEALTH

    NET WT 3.4 OZ (96.4 g)

    62000000207513

    Sensodyne Sensitivity Gum CleanFresh 96g
  • INGREDIENTS AND APPEARANCE
    SENSODYNE   SENSITIVITY AND GUM MINT
    stannous fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-5023
    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, UNSPECIFIED FORM (UNII: 5HK03SA80J)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-5023-011 in 1 CARTON01/06/2020
    196.4 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-5023-021 in 1 CARTON01/06/2020
    223 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:0135-5023-0323 g in 1 TUBE; Type 0: Not a Combination Product01/02/2023
    4NDC:0135-5023-043 in 1 CARTON01/02/2024
    496.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02201/06/2020
    SENSODYNE   SENSITIVITY AND GUM WHITENING
    stannous fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-5024
    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, UNSPECIFIED FORM (UNII: 5HK03SA80J)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-5024-011 in 1 CARTON01/06/2020
    196.4 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-5024-021 in 1 CARTON01/06/2020
    265.2 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02201/06/2020
    SENSODYNE   SENSITIVITY AND GUM CLEAN AND FRESH
    stannous fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-5025
    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
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-5025-011 in 1 CARTON01/06/2021
    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 DrugM02201/06/2021
    Labeler - Haleon US Holdings LLC (079944263)
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