SPL v1
SPL
SPL Set ID b8d5e220-545c-64c1-e053-2995a90acecc
Route
DENTAL
Published
Effective Date 2013-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calcium Cation (36 g) Alcloxa (0.06 g) Aminocaproic Acid (0.07 g) Calcium Phosphate, Dibasic, Anhydrous
Inactive Ingredients
Xylitol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2021-01-01
Description

Precipitated Calcium Carbonate, Dibasic Calcium Phosphate, Aminocaproic Acid, Aluminium Chlorohydroxy Allantoinate

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

Precipitated Calcium Carbonate, Dibasic Calcium Phosphate, Aminocaproic Acid, Aluminium Chlorohydroxy Allantoinate

Section 50565-1

Keep out of reach of children

Section 51727-6

Water, D-Sorbitol Solution, Concentrated Glycerin, Silicon Dioxide, Sodium Cocoyl Glutamate, Polyethylene Glycol 1500, Xanthangum, Mentha Oil, Enzymatically Modified Stevia, Titanium Oxide, Sodium Chloride, Propolis Extract, l-Menthol, Xylitol, Ascorbic Acid, Green Tea Extract, Aloe Extract, Tocopherol Acetate

Section 51945-4

Section 55105-1

For dental care

Section 55106-9

Precipitated Calcium Carbonate, Dibasic Calcium Phosphate, Aminocaproic Acid, Aluminium Chlorohydroxy Allantoinate

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)

Water, D-Sorbitol Solution, Concentrated Glycerin, Silicon Dioxide, Sodium Cocoyl Glutamate, Polyethylene Glycol 1500, Xanthangum, Mentha Oil, Enzymatically Modified Stevia, Titanium Oxide, Sodium Chloride, Propolis Extract, l-Menthol, Xylitol, Ascorbic Acid, Green Tea Extract, Aloe Extract, Tocopherol Acetate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

For dental care

Section 55106-9 (55106-9)

Precipitated Calcium Carbonate, Dibasic Calcium Phosphate, Aminocaproic Acid, Aluminium Chlorohydroxy Allantoinate

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:17.998644 · Updated: 2026-03-14T22:59:12.931286