FDA.reportPublic FDA data

BIS II Tooth

Manufacturer
Jewoo Medical CO.,LTD
Effective date
2026-02-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:36:29

Label at a glance#

ProductBIS II Tooth
Active ingredientDIBASIC CALCIUM PHOSPHATE DIHYDRATE, CALCIUM CARBONATE, .ALPHA.-TOCOPHEROL ACETATE, ALCLOXA
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Precipitated Calcium Carbonate
Tocopherol Acetate
Dibasic Calcium Phosphate Hydrate
Aluminium Chlorohydroxy Allantoinate

INACTIVE INGREDIENT SECTION

Glycerin
D-Sorbitol Solution
Silica
Carboxymethylcellulose Sodium
Sodium Cocoyl Glycinate
Mica
Chitosan
Xylitol
Steviol Glycoside
L-Menthol
Glycyrrhiza Extract
Sophora Flavescens Extract
Scutellaria Baicalensis Root Extract
Salvia Officinalis (Sage) Extract
Calendula Officinalis Flower Extract
Gentiana Lutea Root Extract
Rosmarinus Officinalis (Rosemary) Extract
Aloe Barbadensis Leaf Extract
Citrus Paradisi (Grapefruit) Seed Extract
Lavandula Angustifolia (Lavender) Extract
Propolis Extract
Eucalyptus Globulus Leaf Oil
Chamaecyparis Obtusa Oil
Pistacia Lentiscus (Mastic) Gum
Anethole
fravor
Silver
Activated Carbon
Hydroxyapatite
Water

OTC - PURPOSE SECTION

Aids in the prevention of cavities, plaque, and gingivitis

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of the children

INDICATIONS & USAGE SECTION

Adults and children 2 yrs. older: Brush teeth thoroughly after meals or at least twice a day, or use as directed by a tentist or physician. Do not shallow.

Children under 6 yrs.: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established.

Children under 2 yrs.: Ask a dentist or physician.

WARNINGS SECTION

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

If you accidentally swallow more than used for brushing, seek professional help or contact a poison control center immediately.

DOSAGE & ADMINISTRATION SECTION

for external use only


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1122

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CALCIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69653-202-01BIS II Tooth135 g in 1 TUBEPASTE, DENTIFRICE1351

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69653-20269653-202-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CALCIUM CARBONATEH0G9379FGKACTIM
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0ACTIM
ALCLOXA18B8O9DQA2ACTIB

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
BIS II ToothPRECIPITATED CALCIUM CARBONATE, TOCOPHEROL ACETATE, ALUMINIUM CHLOROHYDROXY ALLANTOINATE, DIBASIC CALCIUM PHOSPHATE HYDRATEJewoo Medical CO.,LTD49f942e6-ceef-5505-e063-6394a90a113f2026-02-03WarningsExact identifier
ndc (package): 69653-202-01
ndc (product): 69653-202
ndc11 (package): 69653020201
spl id: 49f940ac-9e20-53df-e063-6394a90ab4ba
spl set id: 49f942e6-ceef-5505-e063-6394a90a113f

Reported adverse events (FAERS/openFDA)#

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