SPL v3
SPL
SPL Set ID 96a6cee3-4601-a5f8-e053-2995a90ac4df
Route
DENTAL
Published
Effective Date 2013-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Poloxamer 407 (2 g)
Inactive Ingredients
Xylitol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2019-10-01
Description

Poloxamer 407, Simethicone

Medication Information

Warnings and Precautions

Keep away from infants.

Indications and Usage

Use as small amount as a grain of rice.

Dosage and Administration

For dental use only

Description

Poloxamer 407, Simethicone

Section 50565-1

Keep out of reach of children

Section 51727-6

Sorbitol, Water, Xylitol, Stevioside, Cellulose Gum, Xanthan Gum, Potassium Sorbate, Etc.

Section 51945-4

Section 55105-1

For dental care

Section 55106-9

Poloxamer 407, Simethicone

Structured Label Content

Indications and Usage (34067-9)

Use as small amount as a grain of rice.

Dosage and Administration (34068-7)

For dental use only

Warnings and Precautions (34071-1)

Keep away from infants.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Sorbitol, Water, Xylitol, Stevioside, Cellulose Gum, Xanthan Gum, Potassium Sorbate, Etc.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

For dental care

Section 55106-9 (55106-9)

Poloxamer 407, Simethicone

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:56.475572 · Updated: 2026-03-14T22:55:45.140912