Label: O BITS XYLITOL TOOTHPASTE FRESH MINT FLAVOR- 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 September 23, 2022

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  • ACTIVE INGREDIENT

    Sodium Fluoride 0.22%(1,000 ppm fluoride ion)

  • PURPOSE

    Anti-cavity

  • Uses

    ■ Helps protect against cavities, plaque, and gingivitis.

  • Warnings

    Please 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.

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children under 6 years of age

  • Directions

    ■ Adults and children 6 years of age and older: Chew tablet briefly before brushing teeth thoroughly at least twice a day, after each meal or as directed by a dentist or doctor. Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). Children under 6 years of age: Do not use unless directed by a dentist or doctor.

  • Other Information

    ■ Store at 33.8-86℉(1-30°C)

  • Inactive ingredients

    D-Sorbitol, Xylitol(50,000 ppm), Silicon Dioxide, Sodium Cocoyl Glutamate, Microcrystalline Cellulose, Xanthan Gum, Tetrasodium Pyrophosphate, Sodium Bicarbonate, Magnesium Stearate, Combined Flavor(Strongmint Flavor), Combined Flavor(Coolmint Flavor Powder), Combined Flavor(Spearmint Flavor Powder), Hydroxypropylcellulose, Gardenia Yellow, Gardenia Blue, Enzymatically Modified Stevia, Bamboo Salt, Yuja Extract, Sage Extract, Pyridoxine Hydrochloride, L-Menthol

  • O-Bits Xylitol Toothpaste Fresh Mint Flavor (30 tablets)NDC: 82989-010-01

    Image of cello pack

  • O-Bits Xylitol Toothpaste Fresh Mint Flavor (180 tablets)NDC: 82989-010-02

    Image of cello pack

  • INGREDIENTS AND APPEARANCE
    O BITS XYLITOL TOOTHPASTE FRESH MINT FLAVOR 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82989-010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.22 g  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    Xylitol (UNII: VCQ006KQ1E)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82989-010-0130 in 1 CELLO PACK; Type 0: Not a Combination Product09/01/2022
    2NDC:82989-010-02180 in 1 CELLO PACK; Type 0: Not a Combination Product09/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35509/01/2022
    Labeler - Project Noah Inc. (694208735)
    Registrant - Project Noah Inc. (694208735)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sungwon Pharmaceutical Co., Ltd.689787898manufacture(82989-010)