Label: BEANGUARD GARGLE PLUS- sodium fluoride liquid

  • 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 7, 2022

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  • Active Ingredient

    Sodium Fluoride 0.05%

  • Purpose

    Anticavity

  • Use

    Aids in the prevention of dental cavities. Helps to refresh your breath.

  • Warnings

    Do not use more or for longer than directed.

  • Warnings

    This product contains fluorine, so if more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Warnings

    Stop use and ask a dentist if oral irritiation or tooth sensitivity occurs.

  • Warnings

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

  • Inactive Ingredients

    Water, D-Sorbitol Solution, Concentrated Glycerin, Soybean Extract, Ethanol, Xylitol, Raspberry Extract, Sodium Alginate, Polyoxyethylene hydrogenated caster oil, Flavor, Sodium Benzoate, Menthol Pulegium Oil, L-Menthol, Sucralose, Sodium Fluoride, Citric acid, Sodium citrate, Green Tea Extract, Aloe Extract, Sage Extract

  • Other Information

    Store in an airtight container at room temperature (1~30℃).

  • Directions

    Vigorously swish 10 mL of gargle between your teeth for 1 minute and then spit it out.
    Do not swallow.

  • Warnings

    Do not swallow.

  • Label

    Beanguard Gargle Plus Label

  • INGREDIENTS AND APPEARANCE
    BEANGUARD GARGLE PLUS 
    sodium fluoride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77935-303
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SOYBEAN (UNII: L7HT8F1ZOD)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    PENNYROYAL OIL (UNII: AK85U7Y3MV)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ALOE (UNII: V5VD430YW9)  
    CLARY SAGE (UNII: U3HSK5JC0Q)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    RASPBERRY (UNII: 4N14V5R27W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77935-303-01250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/08/2022
    2NDC:77935-303-0210 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/08/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35504/08/2022
    Labeler - BIO3S Co.,Ltd. (694813103)
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