Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 49f942e6-ceef-5505-e063-6394a90a113f
Route
DENTAL
Published
Effective Date 2016-08-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Anhydrous Dibasic Calcium Phosphate (0.04 g) Calcium Cation (0.1 g) .alpha.-tocopherol Alcloxa
Inactive Ingredients
Water Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2026-01-01

Description

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


Medication Information

Warnings and Precautions

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.

Indications and 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.

Dosage and Administration

for external use only



Description

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

Section 50565-1

keep out of reach of the children

Section 51727-6

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

Section 51945-4

Section 55105-1

Aids in the prevention of cavities, plaque, and gingivitis

Section 55106-9

Precipitated Calcium Carbonate

Tocopherol Acetate

Dibasic Calcium Phosphate Hydrate

Aluminium Chlorohydroxy Allantoinate


Structured Label Content

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

for external use only



Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Aids in the prevention of cavities, plaque, and gingivitis

Section 55106-9 (55106-9)

Precipitated Calcium Carbonate

Tocopherol Acetate

Dibasic Calcium Phosphate Hydrate

Aluminium Chlorohydroxy Allantoinate


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)