Glister Multi-action Toothpaste

Glister Multi-action Toothpaste
SPL v2
SPL
SPL Set ID e3f2c049-a0f5-4649-a4aa-11bdb252f951
Route
DENTAL
Published
Effective Date 2022-11-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (2.1 mg)
Inactive Ingredients
Water Sorbitol Hydrated Silica Glycerin Propylene Glycol Sodium Lauryl Sulfate Xylitol Carboxymethylcellulose Sodium, Unspecified Polyethylene Glycol 400 Titanium Dioxide Sodium Benzoate Xanthan Gum Saccharin Sodium Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-03-22

Description

Sodium Fluoride 0.21%

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Sodium Fluoride 0.21%

Use

Aids in the prevention of dental cavities.

Directions

• Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

• Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).

Supervise children as necessary until capable of using without supervision.

• Children under 2 years of age: Consult a dentist or doctor.

Active ingredient

Sodium Fluoride 0.21%

Package Labeling:50g

Inactive ingredients

Water, Sorbitol, Hydrated Silica, Glycerin, Propylene Glycol, Sodium Lauryl Sulfate, Xylitol, Cellulose Gum, PEG-8, Flavor, Titanium Dioxide, Sodium Benzoate, Xanthan Gum, Sodium Saccharin, Blue No. 1

Package Labeling:200g

Keep Out of Reach of Children

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately. under 6 years of age.


Structured Label Content

Use

Aids in the prevention of dental cavities.

Purpose

Anticavity

Directions

• Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

• Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).

Supervise children as necessary until capable of using without supervision.

• Children under 2 years of age: Consult a dentist or doctor.

Active ingredient (Active Ingredient)

Sodium Fluoride 0.21%

Package Labeling:50g

Inactive ingredients (Inactive Ingredients)

Water, Sorbitol, Hydrated Silica, Glycerin, Propylene Glycol, Sodium Lauryl Sulfate, Xylitol, Cellulose Gum, PEG-8, Flavor, Titanium Dioxide, Sodium Benzoate, Xanthan Gum, Sodium Saccharin, Blue No. 1

Package Labeling:200g

Keep Out of Reach of Children (Keep out of reach of children)

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately. under 6 years of age.


Advanced Ingredient Data


Raw Label Data

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