Label: BON SCENT SPARKLING TOOTH WASH- sodium fluoride tablet

  • 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 April 17, 2019

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  • ACTIVE INGREDIENT

    Active ingredients: Sodium Fluoride 1.1%

  • INACTIVE INGREDIENT

    Inactive ingredients:


    DL-Malic acid, DL-Camphor, Glyceryl Monostearate, Glycyrrhizinic acid, Sodium Lauroyl Sarcosinate, Mannitol, Menthol, peppermint oil, Sodium Saccharin dihydrate, Magnesium stearate, Xylitol, Tricalcium phosphate, Calcium Carbonate, Colloid Silica, Sodium bicarbonate, PEG-150, Enzymatically Modified Stevia, Hydroxypropylmethylcellulose

  • PURPOSE

    Purpose: Anticaries & Anticavity

  • WARNINGS

    Warnings:


    - Keep in a cool and dry place.
    - Do not swallow.
    - The fluorine content is 583.21ppm. (Total content should be less than 1,000ppm)
    - If a child under 6 years of age swallowed large quantities, consult a physician or dentist immediately.
    - Keep out of the reach of children under 6 years.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children under 6 years.

  • Uses

    Uses:
    Helps protect against cavities

  • Directions

    Directions:
    - Put 1 tablet into your mouth and wash your gums, teeth, and tongue using your tongue and lips.
    -Lastly rinse several times with water.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of pouch

  • INGREDIENTS AND APPEARANCE
    BON SCENT SPARKLING TOOTH WASH 
    sodium fluoride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72869-010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION9.38 mg  in 853 mg
    Inactive Ingredients
    Ingredient NameStrength
    Mannitol (UNII: 3OWL53L36A)  
    Menthol (UNII: L7T10EIP3A)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize12mm
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72869-010-0230 in 1 POUCH01/02/2019
    1NDC:72869-010-01853 mg in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/02/2019
    Labeler - Lucella Co.,ltd (694733285)
    Registrant - Lucella Co.,ltd (694733285)
    Establishment
    NameAddressID/FEIBusiness Operations
    EQMAXON Corp.557821534manufacture(72869-010)
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