Label: SENSODYNE COMPLETE PROTECTION- stannous fluoride paste
SENSODYNE COMPLETE PROTECTION EXTRA FRESH- stannous fluoride paste

  • NDC Code(s): 0135-0572-02, 0135-0573-02, 0135-0573-03
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 4, 2024

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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 prevent gingivitis, an early form of gum disease.
    • 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 may be 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.
    • store below 30°C (86°F)
  • Inactive ingredients (Mint)

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

  • Inactive ingredients (Extra Fresh)

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

  • Questions or comments?

    1-866-844-2797

  • Additional Information

    SENSODYNE COMPLETE PROTECTION

    What is tooth sensitivity?

    Sensitivity can be a sign that your teeth are vulnerable, as dentin becomes exposed due to enamel loss or gum recession. When exposed dentin comes into contact with hot or cold, sweet or sour, or even your toothbrush, it can trigger the nerve inside the tooth causing a short, sharp pain.

    FRESH FEELING

    PROTECTS ENAMEL

    HELPS WHITEN ENAMEL

    PROTECTS AGAINST PLAQUE

    BUILDS A PROTECTIVE LAYER OVER SENSITIVE AREAS TO SHIELD YOU FROM PAIN*

    CLEAN FEELING

    HELPS PREVENT GINGIVITIS

    *with twice daily brushing

    Why use Sensodyne Complete Protection toothpaste?

    This formulation has been specifically developed to deliver all the toothpaste benefits your sensitive teeth need. Brush twice a day with Sensodyne Complete Protection toothpaste.

    ALWAYS FOLLOW THE LABEL

    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,
    ANTIGINGIVITIS AND CAVITY PREVENTION

    NET WT 3.4 OZ (96.4 g)

    MINT

    COMPLETE PROTECTION

    SENSITIVITY

    ENAMEL

    CLEAN

    GUMS

    FRESH

    PLAQUE

    WHITENING

    62000000207019

    Sensodyne Mint Complete Protection 96g
  • Principal Display Panel (Extra Fresh)

    #1 DENTIST RECOMMENDED BRAND

    SENSODYNE

    TOOTHPASTE FOR SENSITIVE TEETH,
    ANTIGINGIVITIS AND CAVITY PREVENTION

    NET WT 3.4 OZ (96.4 g)

    EXTRA FRESH

    COMPLETE PROTECTION

    SENSITIVITY

    ENAMEL

    CLEAN

    GUMS

    FRESH

    PLAQUE

    ENAMEL

    WHITENING

    62000000207024

    Sensodyne Extra Fresh Complete Protection 96g
  • INGREDIENTS AND APPEARANCE
    SENSODYNE COMPLETE PROTECTION 
    stannous fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0573
    Route of AdministrationDENTAL
    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)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0573-021 in 1 CARTON07/14/2014
    196.4 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-0573-031 in 1 CARTON07/14/2014
    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 DrugM02207/14/2014
    SENSODYNE COMPLETE PROTECTION   EXTRA FRESH
    stannous fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0572
    Route of AdministrationDENTAL
    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)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0572-021 in 1 CARTON07/14/2014
    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 DrugM02207/14/2014
    Labeler - Haleon US Holdings LLC (079944263)
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