Label: PERIOTHERAPY HEALTHY GUMS- sodium fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 10, 2021

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  • Active Ingredient

    Sodium fluoride 0.24%

    (0.14% W/V fluoride ion)

  • Purpose

    Anticavity Fluoride Dentrifice

  • Uses

    Aids in the prevention of dental cavities

  • Warnings

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

  • Warnings

    Keep out of reach of children under 6 years of age.

  • Directions

  • Other information

    • If spilled on fabrics, wash out immediately.
    • This product was sealed with protective packaging at

    the laboratory.
    • If seal is missing, do not use.

  • Inactive Ingredients

    Water (Aqua), Hydrated Silica, Sorbitol, Glycerin, Tetrapotassium Pyrophosphate, Tetrasodium Pyrophosphate, Xylitol, Sodium Lauroyl Sarcosinate, Sodium Chlorite (PeriO2), Mentha Piperita (Peppermint) Oil, Zinc Gluconate (ZincRx), Aloe Barbadensis Leaf Juice, Sodium Benzoate, Ubiquinone.

  • TheraBreath Perio Therapy Healthy Gums Toothpaste

    PerioTherapy Healthy Gums Toothpaste

  • INGREDIENTS AND APPEARANCE
    PERIOTHERAPY HEALTHY GUMS 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72551-253
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.0024 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SODIUM CHLORITE (UNII: G538EBV4VF)  
    MENTHA PIPERITA (UNII: 79M2M2UDA9)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    Product Characteristics
    Colorwhite (Clear) Score    
    ShapeSize
    FlavorMINT (Clean Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72551-253-01100 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35510/01/2018
    Labeler - Dr. Harold Katz, LLC (965507767)
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