Label: PARODONTAX ACTIVE GUM REPAIR BREATH FRESHENER- stannous fluoride paste

  • NDC Code(s): 0135-0737-01, 0135-0737-02
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 9, 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 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, zinc chloride, carrageenan

  • Questions or comments?

    1-855-328-5202

  • Additional information

    ALWAYS FOLLOW THE LABEL

    parodontax ACTIVE GUM REPAIR
    Bleeding gums and bad breath can be a sign of early gum problems.

    New parodontax Active Gum RepairBreath Freshener is a daily toothpaste that helps reverse signs of early gum damage and uses Breath Cleanse Technology* to purify bad breath instead of just masking it.

    • It is specially formulated to kill plaque bacteria at the gumline to help

      keep the gum seal tight and prevent early gum problems.

    • Its Breath Cleanse Technology* utilizes zinc, an antibacterial ingredient

      scientifically proven to purify gases that cause bad breath.

    *compared to parodontax Clean Mint toothpaste

    Distributed by:

    GSK Consumer Healthcare

    Warren, NJ 07059 Made in Germany

    Trademarks owned or licensed by GSK. ©2023 GSK or licensor.

  • Principal Display Panel

    NEW

    parodontax

    DAILY FLUORIDE ANTICAVITY AND ANTIGINGIVITIS TOOTHPASTE

    ACTIVE GUM REPAIR

    HELPS REVERSE SIGNS OF EARLY GUM DAMAGE

    BREATH FRESHENER

    BREATH CLEANSE TECHNOLOGY*

    NET WT 3.4 OZ (96.4 g)

    62000000203673 – Front Carton

    Parodontax Active Gun Repair BF 3.4 oz (96.4 g)
  • INGREDIENTS AND APPEARANCE
    PARODONTAX   ACTIVE GUM REPAIR BREATH FRESHENER
    stannous fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0737
    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)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0737-011 in 1 CARTON01/02/2024
    196.4 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-0737-021 in 1 CARTON01/02/2024
    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 DrugM02201/02/2024
    Labeler - Haleon US Holdings LLC (079944263)
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