Label: PARODONTAX COMPLETE PROTECTION- stannous fluoride paste

  • NDC Code(s): 0135-0634-01
  • 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 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.
    • 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?

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    ALWAYS FOLLOW THE LABEL

  • Principal Display Panel

    NDC 0135-0634-01

    parodontax

    COMPLETE PROTECTION

    WHITENING

    DAILY FLUORIDE ANTICAVITY AND ANTIGINGIVITIS TOOTHPASTE

    HELPS PREVENT BLEEDING GUMS

    ∙FRESHENS BREATH ∙STRENGTHENS ENAMEL ∙DEEP CLEAN ∙WHITENS

    ∙REDUCES BLEEDING GUMS ∙REDUCES INFLAMED GUMS ∙REMOVES PLAQUE ∙GUM SEAL

    NET WT

    3.4 OZ (96.4 g)

    parodontax

    COMPLETE PROTECTION

    Helps prevent bleeding gums

    Healthy gums provide a foundation for strong teeth.

    If you see occasional traces of blood when you brush, it could be a sign of unhealthy gums, eventually weakening that foundation.

    New parodontax Complete Protectionbrings together the expertise behind our specialist gum toothpaste with all you need to help keep your teeth strong, giving you 8 benefits for healthier gums and stronger teeth.

    GENTLY WHITENS

    DEEP CLEANS

    WORKS TO KEEP THE SEAL BETWEEN GUMS AND TEETH TIGHT

    REDUCES RED AND INFLAMED GUMS

    STRENGTHENS AND PROTECTS ENAMEL

    FRESHENS BREATH

    HELPS PREVENT BLEEDING GUMS

    • EFFECTIVELY REMOVES PLAQUE

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

    ©2019 GSK group of companies or its licensor.

    • Distributed by:

    GSK Consumer Healthcare

    Warren, NJ 07059

    1000332

    1000332_parodontax_Complete Protection Whitening_3.4 OZ.JPG
  • INGREDIENTS AND APPEARANCE
    PARODONTAX   COMPLETE PROTECTION
    stannous fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0634
    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:0135-0634-011 in 1 CARTON01/06/2020
    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 DrugM02201/06/2020
    Labeler - Haleon US Holdings LLC (079944263)
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