Label: PARODONTAX- stannous fluoride paste

  • NDC Code(s): 0135-0598-01, 0135-0598-02, 0135-0599-01, 0135-0599-02, view more
    0135-0601-01
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 8, 2024

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  • Active ingredient

    Stannous fluoride 0.454 % (0.110 % 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

    When using this product,

    if irritation occurs discontinue use.

    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 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?

    Call toll-free 1-855-328-5202

  • Principal Display Panel

    NDC 0135-0598-01

    parodontax

    CLEAN MINT

    DAILY FLUORIDE ANTICAVITY AND ANTIGINGIVITIS TOOTHPASTE

    CLINICALLY PROVEN ∙ HEALTHY GUMS AND STRONG TEETH

    Helps prevent bleeding gums

    NET WT

    3.4 OZ (96.4 g)

    PLAQUE BUILDS UP

    GUMS SWELL AND BLEED

    PARODONTAX HELPS REMOVE PLAQUE

    Healthy gums don’t bleed

    If you spit blood when you brush or floss it could be a sign of early gum disease. parodontaxis clinically proven to help reduce bleeding gums by removing the plaque buildup that can cause gums to swell and bleed.

    parodontaxis a daily fluoride toothpaste that also prevents cavities, provides fresh breath and whitening- for healthy gums and strong teeth.

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

    ©2018 GSK group of companies or its licensor.

    Distributed by:

    GSK Consumer Healthcare

    Warren, NJ 07059

    106342XA

    106342XA_parodontax_clean mint_3.4 OZ.JPG
  • Principal Display Panel

    NDC 0135-0599-02

    parodontax

    EXTRA FRESH

    DAILY FLUORIDE ANTICAVITY AND ANTIGINGIVITIS TOOTHPASTE

    CLINICALLY PROVEN ∙ HEALTHY GUMS AND STRONG TEETH

    Helps prevent bleeding gums

    NET WT

    3.4 OZ (96.4 g)

    PLAQUE BUILDS UP

    GUMS SWELL AND BLEED

    PARODONTAX HELPS REMOVE PLAQUE

    Healthy gums don’t bleed

    If you spit blood when you brush or floss it could be a sign of early gum disease. parodontaxis clinically proven to help reduce bleeding gums by removing the plaque buildup that can cause gums to swell and bleed.

    parodontaxis a daily fluoride toothpaste that also prevents cavities, provides fresh breath and whitening- for healthy gums and strong teeth.

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

    ©2018 GSK group of companies or its licensor.

    Distributed by:

    GSK Consumer Healthcare

    Warren, NJ 07059

    106344XA

    106344XA_Parodontax_Extra Fresh_3.4 OZ.JPG
  • Principal Display Panel

    NDC 0135-0601-01

    parodontax

    WHITENING

    DAILY FLUORIDE ANTICAVITY AND ANTIGINGIVITIS TOOTHPASTE

    CLINICALLY PROVEN ∙ HEALTHY GUMS AND STRONG TEETH

    Helps prevent bleeding gums

    NET WT

    3.4 OZ (96.4 g)

    PLAQUE BUILDS UP

    GUMS SWELL AND BLEED

    PARODONTAX HELPS REMOVE PLAQUE

    Healthy gums don’t bleed

    If you spit blood when you brush or floss it could be a sign of early gum disease. parodontaxis clinically proven to help reduce bleeding gums by removing the plaque buildup that can cause gums to swell and bleed.

    parodontaxis a daily fluoride toothpaste that also prevents cavities, provides fresh breath and whitening- for healthy gums and strong teeth.

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

    ©2018 GSK group of companies or its licensor.

    Distributed by:

    GSK Consumer Healthcare

    Warren, NJ 07059

    106345XA

    106345XA_parodontax_whitening_3.4 OZ.JPG
  • INGREDIENTS AND APPEARANCE
    PARODONTAX 
    stannous fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0598
    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)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0598-011 in 1 CARTON12/19/2016
    196.4 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-0598-021 in 1 CARTON05/02/2018
    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 DrugM02212/19/2016
    PARODONTAX 
    stannous fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0599
    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)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0599-011 in 1 CARTON12/19/201610/31/2019
    123 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-0599-021 in 1 CARTON12/19/2016
    296.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02212/19/2016
    PARODONTAX 
    stannous fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0601
    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)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0601-011 in 1 CARTON12/19/2016
    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 DrugM02212/19/2016
    Labeler - Haleon US Holdings LLC (079944263)
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