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SPL v1

SPL

SPL Set ID bcb081cc-30b5-12b1-e053-2a95a90a0858

Route

DENTAL

Published

Effective Date 2013-04-02

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Silicon Dioxide (14 g) .alpha.-tocopherol (0.1 g) Pyrophosphoric Acid (0.5 g)

Inactive Ingredients

Xylitol Water Tribasic Calcium Phosphate

Identifiers & Packaging

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2021-02-01

Description

Silicon Dioxide Tocopherol Acetate Tetrasodium Pyrophosphate

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

Silicon Dioxide Tocopherol Acetate Tetrasodium Pyrophosphate

Section 50565-1

Keep out of reach of children

Section 51727-6

D-Sorbitol Solution

Concentrated Glycerin

Carboxymethylcellulose Sodium

Hydroxyapatite

Medicinal Carbon

Chitosan

Mica

Zeolite

Xylitol

Steviol Glycoside

Papain

Grapefruit Seed Extract

L-Menthol

Mentha Oil

Propolis Extract

Chamomile Extract

Rosemary Extract

Sage Extract

Aloe Extract

Glycyrrhiza Extract

Horsetail Extract

Lavender Oil

Sodium Cocoyl Glutamate

Lauroyl Amidopropyl Dimethyl Glycine Solution

Deionized Water

Section 51945-4

Section 55105-1

For dental care

Section 55106-9

Silicon Dioxide

Tocopherol Acetate

Tetrasodium Pyrophosphate

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

Carboxymethylcellulose Sodium

Hydroxyapatite

Medicinal Carbon

Chitosan

Mica

Zeolite

Xylitol

Steviol Glycoside

Papain

Grapefruit Seed Extract

L-Menthol

Mentha Oil

Propolis Extract

Chamomile Extract

Rosemary Extract

Sage Extract

Aloe Extract

Glycyrrhiza Extract

Horsetail Extract

Lavender Oil

Sodium Cocoyl Glutamate

Lauroyl Amidopropyl Dimethyl Glycine Solution

Deionized Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

For dental care

Section 55106-9 (55106-9)

Silicon Dioxide

Tocopherol Acetate

Tetrasodium Pyrophosphate

Advanced Ingredient Data

[{"name": "XYLITOL", "unii": "VCQ006KQ1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "ACTIB", "strengthNumerator": "14", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "TRIBASIC CALCIUM PHOSPHATE", "unii": "91D9GV0Z28", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL", "unii": "H4N855PNZ1", "classCode": "ACTIB", "strengthNumerator": "0.1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "PYROPHOSPHORIC ACID", "unii": "4E862E7GRQ", "classCode": "ACTIB", "strengthNumerator": "0.5", "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 Carboxymethylcellulose Sodium Hydroxyapatite Medicinal Carbon Chitosan Mica Zeolite Xylitol Steviol Glycoside Papain Grapefruit Seed Extract L-Menthol Mentha Oil Propolis Extract Chamomile Extract Rosemary Extract Sage Extract Aloe Extract Glycyrrhiza Extract Horsetail Extract Lavender Oil Sodium Cocoyl Glutamate Lauroyl Amidopropyl Dimethyl Glycine Solution Deionized Water", "55105-1": "For dental care", "55106-9": "Silicon Dioxide Tocopherol Acetate Tetrasodium Pyrophosphate"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:26.440957 · Updated: 2026-03-14T22:59:25.623456