Label: PARODONTAX ACTIVE GUM REPAIR- stannous fluoride paste

  • NDC Code(s): 0135-0637-01, 0135-0637-02
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 9, 2024

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

  • Active ingredient

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

  • Purposes

    Anticavity

    Antigingivitis

  • Uses

    • aids in the prevention of dental cavities.
    • helps control bleeding gums.
    • 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:
    • brush teeth thoroughly, preferably after each meal or 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.
    • do not store above 25ºC (77ºF)
  • Inactive ingredients

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

  • Questions or comments?

    1-855-328-5202

  • Additional information

    ALWAYS FOLLOW THE LABEL

    Parodontax ACTIVE GUM REPAIR

    To keep your gums healthy,
    It’s important for the seal between the gum and the teeth to be tight. When plaque bacteria builds up along the gum line, this may loosen the gum seal which leads to gum problems.

    New parodontax Active Gum Repairis a daily toothpaste formulated to help reverse early signs of early gum damage by targeting plaque, the main cause of gum problems. The active ingredient kills plaque bacteria at the gum line to help keep the seal tight between gums and teeth and prevent early gum problems.

    Kills plaque bacteria at the gum line

    For tight gum seal

    Healthy gums and teeth

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

    ©2020 GSK group of companies or its licensor.

    Distributed by:

    GSK Consumer Healthcare

    Warren, NJ 07059

  • Principal Display Panel

    NDC 0135-0637-01

    NEW

    parodontax

    DAILY FLUORIDE ANTICAVITY AND ANTIGINGIVITIS TOOTHPASTE

    ACTIVE GUM REPAIR

    HELPS REVERSE SIGNS OF EARLY GUM DAMAGE

    FRESH MINT

    NET WT 3.4 OZ (96.39 g)

    1000839

    Parodontax Active Gum Repair 3.4 OZ
  • INGREDIENTS AND APPEARANCE
    PARODONTAX   ACTIVE GUM REPAIR
    stannous fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0637
    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)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0637-011 in 1 CARTON01/04/2021
    196.4 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-0637-021 in 1 CARTON01/04/2021
    222.7 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)