Label: BEANGUARD GARGLE- sodium chloride 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 October 8, 2021

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  • Active Ingredients

    Sodium Chloride 0.5%

  • Purpose

    Anticavity

  • Uses

    Helps maintain the hygiene of the oral
    cavity.Gives ongoing freshness and helps
    prevent cavities with removing bad breath.

  • Warnings

    Do not swallow.

  • Warnings

    Keep out of reach of children under 6 years old.

    If accidently swallowed, get medical help or consult with doctor

  • Warnings

    Stop Use and Ask a Doctor if : red spots, swelling, itching symptoms occur.

  • Warnings

    When Using this product : Be careful not to swallow or get into eyes or ears.

  • Inactive Ingredients

    water, sodium benzoate, bean extract

  • Directions

    Take one pouch and gargle for 30 seconds.
    Do not swallow and spit it out

  • Other Information

    Other information
    Avoid exposing the product in direct sunlight
    and excessive heat. Store at room temperature
    20°-25°C (68°-77°F

  • Warnings

    If accidently swallowed, get medical help or consult with doctor.

  • Display Panel

    Beanguard Gargle

  • INGREDIENTS AND APPEARANCE
    BEANGUARD GARGLE 
    sodium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77935-302
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BEAN (UNII: 8WB9PV3YW5)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77935-302-015 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/08/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34910/08/2021
    Labeler - BIO3S Co.,Ltd. (694813103)
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