Drug Facts

Drug Facts

SPL v4

SPL

SPL Set ID 32de6647-5a5d-1f41-e054-00144ff88e88

Route

DENTAL

Published

Effective Date 2010-12-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Carbonate Ion (15.85 g)

Inactive Ingredients

Glycerin Rosin Water

Identifiers & Packaging

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2016-05-12

Description

Calcium Carbonate

Medication Information

Warnings and Precautions

- do not swallow when using this product

- if more than used for rinsing is accidentally swallowed, get medical helps or contact a poison control center right away

Indications and Usage

use when is needed

Dosage and Administration

apply proper amount on your toothbrush

Description

Calcium Carbonate

Section 50565-1

keep out of reach of the children

Section 51727-6

glycerine, rosin, water, etc.

Section 51945-4

Section 55105-1

for dental care

Section 55106-9

Calcium Carbonate

Structured Label Content

Indications and Usage (34067-9)

use when is needed

Dosage and Administration (34068-7)

apply proper amount on your toothbrush

Warnings and Precautions (34071-1)

- do not swallow when using this product

- if more than used for rinsing is accidentally swallowed, get medical helps or contact a poison control center right away

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

glycerine, rosin, water, etc.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

for dental care

Section 55106-9 (55106-9)

Calcium Carbonate

Advanced Ingredient Data

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ROSIN", "unii": "88S87KL877", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBONATE ION", "unii": "7UJQ5OPE7D", "classCode": "ACTIB", "strengthNumerator": "15.85", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "use when is needed", "34068-7": "apply proper amount on your toothbrush", "34071-1": "- do not swallow when using this product - if more than used for rinsing is accidentally swallowed, get medical helps or contact a poison control center right away", "50565-1": "keep out of reach of the children", "51727-6": "glycerine, rosin, water, etc.", "55105-1": "for dental care", "55106-9": "Calcium Carbonate"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:58.831310 · Updated: 2026-03-14T22:55:47.133560