Otc - Active Ingredient
Precipitated Calcium Carbonate
Tocopherol Acetate
Dibasic Calcium Phosphate Hydrate
Aluminium Chlorohydroxy Allantoinate
Bis Ii Tooth Paste, Dentifrice
FDA Label NDC 69653-202
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jewoo Medical Co.,ltd for the product Bis Ii Tooth (NDC 69653-202). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, inactive ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Otc - Purpose
Aids in the prevention of cavities, plaque, and gingivitis
Otc - 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
Package Label.Principal Display Panel
1 (Label135)
2 (Label135tube)
* Please review the disclaimer below.
