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)

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

Section 55106-9

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

Structured Label Content

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

Warnings and Precautions (34071-1)

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

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

Section 55106-9 (55106-9)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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