Label: SENSODYNE SENSITIVITY GUM AND ENAMEL MINT- stannous fluoride paste

  • NDC Code(s): 0135-5022-01, 0135-5022-02, 0135-5022-03
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 7, 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 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 specially formulated to help prevent staining.
    • do not store above 25°C (77°F)
  • Inactive ingredients

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

  • Questions or comments?

    1-866-844-2797

  • Additional Information

    ALWAYS FOLLOW THE LABEL

    SENSODYNE

    SENSITIVITY
    GUM &
    ENAMEL

    Gum recession and enamel wear are the two leading causes of sensitive teeth. Gum problems are caused by a build-up of plaque bacteria along the gum line. Enamel wear can be caused by acids in

    everyday foods and drinks.

    Sensodyne Sensitivity, Gum & Enamelis a daily toothpaste with a clinically proven ingredient to relieve sensitive teeth and improve gum health, while also strengthening the enamel.

    1. Builds a protective layer over the sensitive areas
    2. Formula with stannous fluoride targets & removes plaque bacteria** in between teeth & gumline.
    3. Strengthens enamel surface and protects teeth from acids, while being gentle on enamel.

    *with twice daily brushing.
    **plaque bacteria associated with gingivitis to help reduce swollen, bleeding gums.

    Trademarks owned or licensed by GSK. @2022 GSK or licensor.

    Distributed by: GSK Consumer Healthcare
    Warren, NJ 07059. Made in Germany

    CARTON
    RECYCLE

  • Principal Display Panel

    new

    #1 Dentist RecommendED Brand

    SENSODYNE

    MINT
    SENSITIVITY GUM & ENAMEL

    FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH,
    ANTI-GINGIVITIS AND CAVITY PREVENTION

    NEW WT 3.4 OZ (96.4 g)

    20041 Front Carton

    Sensodyne Sensitivity Gum & Enamel Mint 3.4 oz carton
  • INGREDIENTS AND APPEARANCE
    SENSODYNE   SENSITIVITY GUM AND ENAMEL MINT
    stannous fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-5022
    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:0135-5022-011 in 1 CARTON01/02/2023
    196.4 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-5022-021 in 1 CARTON01/02/2023
    265.2 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:0135-5022-032 in 1 CARTON01/02/2024
    396.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02201/02/2023
    Labeler - Haleon US Holdings LLC (079944263)
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