SPL v1
SPL
SPL Set ID f126df43-b31a-13c2-e053-2a95a90a523c
Route
DENTAL
Published
Effective Date 2023-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chloride Ion (3 g) Calcium Cation (33 g)
Inactive Ingredients
Xylitol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2023-01-01

Description

Sodium Chloride, Precipitated Calcium Carbonate


Medication Information

Warnings and Precautions

Warnings

Keep out of reach of children

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

Other Information

■ Store in an airtight container at room temperature

■ Date of use : 36 months from the date of manufacture

Indications and Usage

Apply an appropriate amount to your toothbrush and brush your teeth by brushing.

Dosage and Administration

For dental use only

Description

Sodium Chloride, Precipitated Calcium Carbonate

Section 50565-1

Keep out of reach of children

Section 51727-6

D-Sorbitol Solution

Concentrated Glycerin

Polyethylene Glycol 1500

Xanthan gum

Titanium Oxide

Silicon Dioxide

Sodium Cocoyl Glutamate

Enzymatically Modified Stevia

Xylitol

Ascorbic Acid

Tocopherol Acetate

Propolis Extract

Green Tea Extract

Aloe Extract

l-Menthol

Mentha Oil

Lemon Oil

Water

Section 51945-4

Section 55105-1

aids in the prevention of dental cavities

plaque removal (anti-plaque)

prevention of periodontal disease, prevention of gum disease

Section 55106-9

Sodium Chloride, Precipitated Calcium Carbonate


Structured Label Content

Indications and Usage (34067-9)

Apply an appropriate amount to your toothbrush and brush your teeth by brushing.

Dosage and Administration (34068-7)

For dental use only

Warnings and Precautions (34071-1)

Warnings

Keep out of reach of children

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

Other Information

■ Store in an airtight container at room temperature

■ Date of use : 36 months from the date of manufacture

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

D-Sorbitol Solution

Concentrated Glycerin

Polyethylene Glycol 1500

Xanthan gum

Titanium Oxide

Silicon Dioxide

Sodium Cocoyl Glutamate

Enzymatically Modified Stevia

Xylitol

Ascorbic Acid

Tocopherol Acetate

Propolis Extract

Green Tea Extract

Aloe Extract

l-Menthol

Mentha Oil

Lemon Oil

Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

aids in the prevention of dental cavities

plaque removal (anti-plaque)

prevention of periodontal disease, prevention of gum disease

Section 55106-9 (55106-9)

Sodium Chloride, Precipitated Calcium Carbonate


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)