Label: FRAICHE KIDS BUBBLE GUM MOUTHWASH- sodium fluoride liquid

  • NDC Code(s): 83592-802-10
  • Packager: True Marker Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 27, 2024

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  • Active Ingredient 

    SODIUM FLUORIDE  0.05%

    (0.02% w/v fluoride ion)

  • Purpose

    Dental Caries Preventive

  • Uses

     Aids in the prevention of dental cavities.

  • Warnings

    Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    • Use once a day after brushing your teeth with a toothpaste
    • Remove cap
    • Hold bottle upright and squeeze. Fill to FILL LINE (10mL)
    • Vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
    • Do not swallow the rinse
    • Do not eat or drink for 30 minutes after rinsing
    • Instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
    • Supervise children as necessary until capable of using without supervision
    • Children under 6 years of age: consult a dentist or doctor
  • Other information

    • Store at controlled room temperature, 68-77°F (20-25°C).
    • Do not use if safety seal is broke or missing.
  • Inactive Ingredients

    Cetylpyridinium chloride, dipotassium glycyrrhizinate, disodium phosphate, flavor, glycerin, poloxamer 407, polysorbate 20, propylene glycol, sodium benzoate, sodium phosphate, sorbitol, stevia rebaudiana leaf/stem extract, water, xylitol.

  • This product does not contain ethyl alcohol.

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    FRAICHE KIDS BUBBLE GUM MOUTHWASH 
    sodium fluoride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83592-802
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    SORBITOL (UNII: 506T60A25R)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83592-802-10300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02107/01/2024
    Labeler - True Marker Pharmaceuticals, Inc. (119046582)
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