Label: SENSODYNE REPAIR AND PROTECT- stannous fluoride paste
SENSODYNE REPAIR AND PROTECT EXTRA FRESH- stannous fluoride paste
SENSODYNE REPAIR AND PROTECT WHITENING- stannous fluoride paste

  • NDC Code(s): 0135-0547-02, 0135-0548-01, 0135-0548-02, 0135-0575-01
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 6, 2024

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  • 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 product 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.
    • store above 30°C (86°F)
  • Inactive ingredients (Mint)

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

  • Inactive ingredients (Extra Fresh)

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

  • Inactive ingredients (Whitening)

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

  • Questions or comments?

    1-866-844-2797

  • Other Information

    SENSODYNE REPAIR & PROTECT DEEP REPAIR

    Sensodyne Repair & Protecthas a clinically proven ingredient. With twice daily brushing it helps to repair deep inside the tubules and relieves sensitivity to help you enjoy life without worrying about the pain of sensitive teeth.

    EXPOSED DENTIN; CAUSE OF SENSITIVE TEETH

    TINY HOLES

    GETS DEEP INSIDE THESE HOLES

    TO HELP REPAIR THESE HOLES

    WHICH HELPS PROTECT FROM PAIN*

    Daily use fluoride toothpaste to provide long lasting sensitivity relief, whilst also keeping your teeth and gums healthy. *

    *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†

  • Principal Display Panel (Mint)

    #1 DENTIST RECOMMENDED BRAND

    SENSODYNE

    FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    MINT

    REPAIR & PROTECT

    DEEP REPAIR

    NET WT 3.4 OZ (96.4 g)

    62000000207021

    Sensodyne Repair and Protect Mint 96g
  • Principal Display Panel (Extra Fresh)

    #1 DENTIST RECOMMENDED BRAND

    SENSODYNE

    FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    EXTRA FRESH

    REPAIR & PROTECT

    DEEP REPAIR

    NET WT 3.4 OZ (96.4 g)

    62000000207114

    Sensodyne Repair and Protect Extra Fresh 96g
  • Principal Display Panel (Whitening)

    #1 DENTIST RECOMMENDED BRAND

    SENSODYNE

    FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    WHITENING

    REPAIR & PROTECTED

    DEEP REPAIR

    NET WT 3.4 OZ (96.4 g)

    62000000207026

    Sensodyne Repair and Protect Whitening 96g
  • INGREDIENTS AND APPEARANCE
    SENSODYNE   REPAIR AND PROTECT
    stannous fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0548
    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)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0548-021 in 1 CARTON06/28/2021
    196.4 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-0548-011 in 1 CARTON06/28/2021
    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 DrugM02206/28/2021
    SENSODYNE   REPAIR AND PROTECT EXTRA FRESH
    stannous fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0547
    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)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0547-021 in 1 CARTON06/28/2021
    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 DrugM02206/28/2021
    SENSODYNE   REPAIR AND PROTECT WHITENING
    stannous fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0575
    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)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0575-011 in 1 CARTON06/28/2021
    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 DrugM02206/28/2021
    Labeler - Haleon US Holdings LLC (079944263)
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