Label: BEANGUARD SENSITIVETOOTHPASTE- hydrated silica, potassium nitrate, sodium fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 December 22, 2022

If you are a consumer or patient please visit this version.

  • Active ingredients

    Hydrated Silica 17.5%
    Potassium Nitrate 5%
    Sodium Fluoride 0.221%

  • Purposes

    Hydrated Silica 17.5% Antiplaque
    Potassium Nitrate 5% Antihypersensitivity
    Sodium Fluoride 0.221% Anticavity

  • Uses

    ■ builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact
    ■ aids in the prevention of dental cavities
    ■ helps interfere with harmful effects of plaque associated with gingivitis

  • Warnings

    Do not use it for purposes other than intended.
    Keep out of reach of children under 6 years of age.
    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison
    Control Center right away.
    Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks.

  • Warnings

    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Warnings

    Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks.

  • Warnings

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

  • Warnings

    Do not use it for purposes other than intended.

  • Directions

    ■ Adults and children 2 years of age and older:

    Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

    Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).

    Supervise children as necessary until capable of using without supervision.
    Children under 2 years of age: Consult a dentist or doctor.

  • Inactive ingredients

    Sorbitol, Water; Glycerin, Glycine Max Seed Extract, Xylitol, Sodium Cocoyl Glutamate, Sodium Methyl Cocoyl Taurat, Cellulose Gum, Hydroxyapatite, Stevioside, Menthol, Rucola Flavor, Cooling Flavor, Pine Flavor, Centella Asiatics Extract, Aloe Barbadensis Leaf Extract, Chamomilla Recutita Flower Extract, Eucalyptus Globulus Leaf Extract, Rosmarinus Officinalis Leaf Extract, Calendula Officinalis Flower Extract

  • Display Panel

    Toothpaste label

  • INGREDIENTS AND APPEARANCE
    BEANGUARD SENSITIVETOOTHPASTE 
    hydrated silica, potassium nitrate, sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77935-401
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 g  in 100 mL
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.221 g  in 100 mL
    HYDRATED SILICA (UNII: Y6O7T4G8P9) (HYDRATED SILICA - UNII:Y6O7T4G8P9) HYDRATED SILICA17.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    MARITIME PINE (UNII: 50JZ5Z98QY)  
    STEVIOSIDE (UNII: 0YON5MXJ9P)  
    MENTHOL (UNII: L7T10EIP3A)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    SORBITOL (UNII: 506T60A25R)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    CHAMOMILE (UNII: FGL3685T2X)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    ROSEMARY (UNII: IJ67X351P9)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    BRASSICA OLERACEA WHOLE (UNII: FQ4E5MHM9Q)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77935-401-01120 mL in 1 TUBE; Type 0: Not a Combination Product12/27/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35612/27/2022
    Labeler - BIO3S Co.,Ltd. (694813103)
    Registrant - BIO3S Co.,Ltd. (694813103)
    Establishment
    NameAddressID/FEIBusiness Operations
    BIO3S Co.,Ltd.694813103manufacture(77935-401)