Label: BEANGUARD SENSITIVETOOTHPASTE- hydrated silica, potassium nitrate, sodium fluoride paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 77935-401-01 - Packager: BIO3S Co.,Ltd.
- 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
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- Active ingredients
- Purposes
- Uses
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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
- Warnings
- Warnings
- Warnings
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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
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INGREDIENTS AND APPEARANCE
BEANGUARD SENSITIVETOOTHPASTE
hydrated silica, potassium nitrate, sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77935-401 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 5 g in 100 mL SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.221 g in 100 mL HYDRATED SILICA (UNII: Y6O7T4G8P9) (HYDRATED SILICA - UNII:Y6O7T4G8P9) HYDRATED SILICA 17.5 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:77935-401-01 120 mL in 1 TUBE; Type 0: Not a Combination Product 12/27/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 12/27/2022 Labeler - BIO3S Co.,Ltd. (694813103) Registrant - BIO3S Co.,Ltd. (694813103) Establishment Name Address ID/FEI Business Operations BIO3S Co.,Ltd. 694813103 manufacture(77935-401)