BEANGUARD SENSITIVETOOTHPASTE- hydrated silica, potassium nitrate, sodium fluoride paste, dentifrice 
BIO3S Co.,Ltd.

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.

----------

77935-401 BeanGuard Sensitive toothpaste

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

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)

Revised: 12/2022
Document Id: f0669f7c-b12c-6015-e053-2995a90aae3c
Set id: f0669f7c-b12b-6015-e053-2995a90aae3c
Version: 1
Effective Time: 20221222
 
BIO3S Co.,Ltd.