Label: POLIDENT PROPARTIAL- stannous fluoride paste

  • NDC Code(s): 0135-0710-01, 0135-0710-02, 0135-0710-03
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 7, 2024

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  • Active ingredient

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

  • Purposes

    Anticavity, Antigingivitis

  • 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.
  • Warnings

    Stop use and ask a dentist if

    • 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 under 6 years of age.

    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 2 years of age and older:
      • apply toothpaste onto a toothbrush.
      • brush teeth thoroughly, preferably after each meal at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing.
    • to minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing and rinsing until good habits are established.
    • children under 2 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.
    • store below 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

  • Questions or comments?

    1-866-844-2796

  • Additional Information

    ALWAYS FOLLOW THE LABEL

    Your partial can act as a bacteria magnet, attracting more odor-causing bacteria, plaque and debris that if not cleaned can damage your natural teeth.

    NEW POLIDENT ProPartialis a simple 3-step range specially developed to cleanse partial dentures, help strengthen teeth, and help protect against odor-causing bacteria.

    STEP 1PURIFYYour Partial with Foam Cleanser

    STEP 2 STRENGHTENYour Teeth + Gums with Toothpaste

    STEP 3 PROTECTYour Teeth with Mouthwash

    Strengthens by remineralizing teeth, including vulnerable teeth next to the partial and helps fight plaque bacteria*.

    *associated with gingivitis, an early form of gum disease

    1-866-844-2796

    Distributed by:

    GSK Consumer Healthcare,Warren, NJ 07059

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

    ©2020 GSK group of companies or its licensor.

    Made in Germany.

    Best used before the end of: see end of carton.

  • Principal Display Panel

    NDC 0135-0710-01

    POLIDENT

    PROPARTIAL

    Fluoride Anticavity and Antigingivitis Toothpaste

    new

    STEP 2 STRENGTHEN TOOTHPASTE FOR TEETH AND GUMS

    • Actively remineralizes teeth + helps fight plaque bacteria*

    Net wt 3.4 oz (96.4 g)

    62000000050516: Tube

    62000000050517: Carton

    Polident ProPartial Paste 3.4 oz
  • INGREDIENTS AND APPEARANCE
    POLIDENT   PROPARTIAL
    stannous fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0710
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 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
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0710-011 in 1 CARTON01/04/2021
    196.4 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-0710-021 in 1 CARTON01/04/2021
    265.2 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:0135-0710-031 in 1 CARTON01/04/2021
    322.7 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02201/04/2021
    Labeler - Haleon US Holdings LLC (079944263)
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