413ab9ba-7930-0f0d-e054-00144ff8d46c

SPL v2

SPL

SPL Set ID 413ab9ba-7930-0f0d-e054-00144ff8d46c

Route

dental

Published

Effective Date 2013-04-02

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

calcium cation (20 g) .alpha.-tocopherol (0.2 g) silicon dioxide (6 g)

Inactive Ingredients

sorbitol water

Identifiers & Packaging

Marketing Status

unapproved drug other active Since 2016-05-01

Description

Tricalcium Phosphate, Dental Type Silica (Silicon Dioxide), Tocopheryl Acetate (.ALPHA.-TOCOPHEROL ACETATE)

Medication Information

Warnings and Precautions

Alright container, store at room temperature (1-30)

Active Ingredient

Tricalcium Phosphate, Dental Type Silica (Silicon Dioxide), Tocopheryl Acetate (.ALPHA.-TOCOPHEROL ACETATE)

Indications and Usage

Spin the lever at the bottom of the product clockwise
Rub the silicon tip smoothly on the sensitive area (60 seconds)
Rinse your mouth after 30 seconds once the product is absorbed)

Dosage and Administration

For dental use only

Description

Tricalcium Phosphate, Dental Type Silica (Silicon Dioxide), Tocopheryl Acetate (.ALPHA.-TOCOPHEROL ACETATE)

Section 50565-1

Keep out of reach of children

Section 51727-6

Sorbitol, water, etc.

Section 51945-4

Section 55105-1

For dental care

Structured Label Content

Warnings and Precautions (34071-1)

Alright container, store at room temperature (1-30)

Active Ingredient (55106-9)

Tricalcium Phosphate, Dental Type Silica (Silicon Dioxide), Tocopheryl Acetate (.ALPHA.-TOCOPHEROL ACETATE)

Indications and Usage (34067-9)

Spin the lever at the bottom of the product clockwise
Rub the silicon tip smoothly on the sensitive area (60 seconds)
Rinse your mouth after 30 seconds once the product is absorbed)

Dosage and Administration (34068-7)

For dental use only

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Sorbitol, water, etc.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

For dental care

Advanced Ingredient Data

[{"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALCIUM CATION", "unii": "2M83C4R6ZB", "classCode": "ACTIM", "strengthNumerator": "20", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": ".ALPHA.-TOCOPHEROL", "unii": "H4N855PNZ1", "classCode": "ACTIB", "strengthNumerator": "0.2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Spin the lever at the bottom of the product clockwise Rub the silicon tip smoothly on the sensitive area (60 seconds) Rinse your mouth after 30 seconds once the product is absorbed)", "34068-7": "For dental use only", "34071-1": "Alright container, store at room temperature (1-30)", "50565-1": "Keep out of reach of children", "51727-6": "Sorbitol, water, etc.", "55105-1": "For dental care", "55106-9": "Tricalcium Phosphate, Dental Type Silica (Silicon Dioxide), Tocopheryl Acetate (.ALPHA.-TOCOPHEROL ACETATE)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:21.762792 · Updated: 2026-03-14T22:54:46.340416