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SPL v2

SPL

SPL Set ID d1ff3b5d-26e2-9eee-e053-2995a90adbc2

Route

DENTAL

Published

Effective Date 2021-11-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.4 g) Calcium Phosphate, Dibasic, Anhydrous (0.07 g) Calcium Cation (36 g) Alcloxa (0.06 g) Aminocaproic Acid

Inactive Ingredients

Xylitol Water

Identifiers & Packaging

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2021-11-30

Description

Sodium Monofluorophosphate, 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

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

Section 50565-1

Keep out of reach of children

Section 51727-6

D-Sorbitol Solution

Concentrated Glycerin

Polyethylene Glycol 1500

Xanthangum

Sodium Cocoyl Glutamate

Silicon Dioxide

Titanium Oxide

Enzymatically Modified Stevia

Xylitol

Sodium Chloride

Ascorbic Acid

Mentha Oil

l-Menthol

Spearmint Oil

Water

Section 51945-4

Section 55105-1

For dental care

Section 55106-9

Sodium Monofluorophosphate, 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)

D-Sorbitol Solution

Concentrated Glycerin

Polyethylene Glycol 1500

Xanthangum

Sodium Cocoyl Glutamate

Silicon Dioxide

Titanium Oxide

Enzymatically Modified Stevia

Xylitol

Sodium Chloride

Ascorbic Acid

Mentha Oil

l-Menthol

Spearmint Oil

Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

For dental care

Section 55106-9 (55106-9)

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

Advanced Ingredient Data

[{"name": "XYLITOL", "unii": "VCQ006KQ1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "0.4", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS", "unii": "L11K75P92J", "classCode": "ACTIB", "strengthNumerator": "0.07", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "CALCIUM CATION", "unii": "2M83C4R6ZB", "classCode": "ACTIB", "strengthNumerator": "36", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "ALCLOXA", "unii": "18B8O9DQA2", "classCode": "ACTIB", "strengthNumerator": "0.06", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "AMINOCAPROIC ACID", "unii": "U6F3787206", "classCode": "ACTIB", "strengthNumerator": "0.06", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Apply an appropriate amount to your toothbrush and brush your teeth by brushing.", "34068-7": "For dental use only", "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", "50565-1": "Keep out of reach of children", "51727-6": "D-Sorbitol Solution Concentrated Glycerin Polyethylene Glycol 1500 Xanthangum Sodium Cocoyl Glutamate Silicon Dioxide Titanium Oxide Enzymatically Modified Stevia Xylitol Sodium Chloride Ascorbic Acid Mentha Oil l-Menthol Spearmint Oil Water", "55105-1": "For dental care", "55106-9": "Sodium Monofluorophosphate, Precipitated Calcium Carbonate, Dibasic Calcium Phosphate, Aminocaproic Acid, Aluminium Chlorohydroxy Allantoinate"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:50.488420 · Updated: 2026-03-14T22:59:59.287312