BeanGuard Sensitivetoothpaste

Manufacturer
BIO3S Co.,Ltd.
Effective date
2022-12-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:52:42

Label at a glance#

ProductBeanGuard Sensitivetoothpaste
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE, HYDRATED SILICA
Label structure11 sections

Indications and 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

Dosage and administration

■ 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.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

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

Purposes

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

■ 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

WARNINGS SECTION

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

OTC - WHEN USING SECTION

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

Warnings

OTC - STOP USE SECTION

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

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Warnings

OTC - DO NOT USE SECTION

Do not use it for purposes other than intended.

Directions

DOSAGE & ADMINISTRATION SECTION

■ 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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Toothpaste labelToothpaste label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77935-401-012024-01-30C16284748780-11030e365-627b-111a-e063-dadaa90a10e277935-401 BeanGuard Sensitive toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77935-401-01BeanGuard Sensitivetoothpaste120 mL in 1 TUBEPASTE, DENTIFRICE1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77935-401BEANGUARD SENSITIVETOOTHPASTE (HYDRATED SILICA, POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [BIO3S CO.,LTD.]1Legacy NDC, 1 package rows20221229_f0669f7c-b12b-6015-e053-2995a90aae3c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77935-40177935-401-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f0669f7c-b12c-6015-e053-2995a90aae3cf0669f7c-b12b-6015-e053-2995a90aae3c2022-12-22WarningsExact identifier
spl id: f0669f7c-b12c-6015-e053-2995a90aae3c
spl set id: f0669f7c-b12b-6015-e053-2995a90aae3c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.