BIS II TOOTH- precipitated calcium carbonate, tocopherol acetate, aluminium chlorohydroxy allantoinate, dibasic calcium phosphate hydrate paste, dentifrice

BIS II Tooth by

Drug Labeling and Warnings

BIS II Tooth by is a Otc medication manufactured, distributed, or labeled by Jewoo Medical CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

INACTIVE INGREDIENT

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

PURPOSE

Aids in the prevention of cavities, plaque, and gingivitis

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

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

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

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIS II TOOTH 
precipitated calcium carbonate, tocopherol acetate, aluminium chlorohydroxy allantoinate, dibasic calcium phosphate hydrate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69653-200
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) (ANHYDROUS DIBASIC CALCIUM PHOSPHATE - UNII:L11K75P92J)	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	0.04 g  in 100 g
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	0.1 g  in 100 g
ALCLOXA (UNII: 18B8O9DQA2) (ALCLOXA - UNII:18B8O9DQA2)	ALCLOXA	0.04 g  in 100 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1)	.ALPHA.-TOCOPHEROL	0.04 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69653-200-01	20 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/01/2026

Labeler - Jewoo Medical CO.,LTD (689512541)

Registrant - Jewoo Medical CO.,LTD (689512541)

Establishment
Name	Address	ID/FEI	Business Operations
Jewoo Medical CO.,LTD		689512541	manufacture(69653-200)