Drug Facts

Drug Facts

SPL v2

SPL

SPL Set ID 1b5a5f59-fa6a-4ce6-a360-502fb651eb1a

Route

DENTAL

Published

Effective Date 2015-02-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Silicon Dioxide (7 g) .alpha.-tocopherol (0.2 g) Hydrogen Peroxide (2.14 g)

Inactive Ingredients

Xylitol Water

Identifiers & Packaging

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2015-01-22

Description

colloidal silicon dioxide, tocopherol acetate, 35% hydrogen peroxide solution

Medication Information

Warnings and Precautions

store at room temperature

Indications and Usage

brush teeth with your toothbrush

Dosage and Administration

for dental use only

Description

colloidal silicon dioxide, tocopherol acetate, 35% hydrogen peroxide solution

Section 50565-1

keep out of reach of the children

Section 51727-6

xylityl, sorbitol solution 70%, polyethylene glycol 1500, carboxymethylcellulose sodium, xanthan gum, poly vinyl pirrolidone, sodium stannate, etc.

Section 51945-4

Section 55105-1

for dental care

Section 55106-9

colloidal silicon dioxide, tocopherol acetate, 35% hydrogen peroxide solution

Structured Label Content

Indications and Usage (34067-9)

brush teeth with your toothbrush

Dosage and Administration (34068-7)

for dental use only

Warnings and Precautions (34071-1)

store at room temperature

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

xylityl, sorbitol solution 70%, polyethylene glycol 1500, carboxymethylcellulose sodium, xanthan gum, poly vinyl pirrolidone, sodium stannate, etc.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

for dental care

Section 55106-9 (55106-9)

colloidal silicon dioxide, tocopherol acetate, 35% hydrogen peroxide solution

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": "7", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": ".ALPHA.-TOCOPHEROL", "unii": "H4N855PNZ1", "classCode": "ACTIM", "strengthNumerator": "0.2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "HYDROGEN PEROXIDE", "unii": "BBX060AN9V", "classCode": "ACTIB", "strengthNumerator": "2.14", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "brush teeth with your toothbrush", "34068-7": "for dental use only", "34071-1": "store at room temperature", "50565-1": "keep out of reach of the children", "51727-6": "xylityl, sorbitol solution 70%, polyethylene glycol 1500, carboxymethylcellulose sodium, xanthan gum, poly vinyl pirrolidone, sodium stannate, etc.", "55105-1": "for dental care", "55106-9": "colloidal silicon dioxide, tocopherol acetate, 35% hydrogen peroxide solution"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:21.762002 · Updated: 2026-03-14T22:54:46.340416