Label: SYNEDENT FLX- sodium fluoride mouthwash

  • 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 March 5, 2020

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  • Active Ingredients

    Sodium fluoride 0.05% (0.02% fluoride ion)

  • Purpose

    Anticavity

  • Directions

    Adults and children 6 years of age and older: Use once a day after brushing your teeth with toothpaste. Vigorously swish 10 milliliters (2 teaspoons) 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.

  • USE

    Aids in the prevention of dental cavities

  • Warnings

    Keep out of reach of children.

    If more than indicated is swallowed, get medical attention or contact a Poison Control Center right away. Contains shellfish derivatives. Not to be used by pets. Do not use if safety seal is broken or missing.

  • Warning

    Keep out of reach of children

  • Inactive Ingredients

    Water, Sorbitol, Glycerin, Xylitol, Polysorbate 20, Peppermint Oil, Benzoic Acid, ChitoTek (Chitosan Argininamide), Sodium Hydroxide

  • Other Information

    Store at room temperature

  • Question?

    Call toll-free 855-774-7962

  • Label Sample

    LabelSample

  • INGREDIENTS AND APPEARANCE
    SYNEDENT FLX 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42368-005
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.02 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 49.882 g  in 100 mL
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42368-005-01300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35512/01/2017
    Labeler - Synedgen Inc. (830276353)
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