Gleem Whitening

Gleem Whitening
SPL v5
SPL
SPL Set ID c313a800-f9f4-3a51-e053-2a95a90a019e
Route
DENTAL
Published
Effective Date 2019-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.5 mg)
Inactive Ingredients
Carboxypolymethylene Sodium Acid Pyrophosphate Carboxymethylcellulose Sodium Activated Charcoal Polysorbate 80 Water Saccharin Sodium Hydrated Silica Sodium Lauryl Sulfate Sucralose Titanium Dioxide Sorbitol Sodium Hydroxide Mica

Identifiers & Packaging

Pill Appearance
Color: black
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-04
Description

Drug Facts

Purpose

Anticavity toothpaste

Medication Information

Purpose

Anticavity toothpaste

Description

Drug Facts

Use

helps protect against cavities

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children under 6 yrs. of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
    • do not swallow
    • to minimize swallowing use a pea-sized amount in children under 6
    • supervise children's brushing until good habits are established
  • children under 2 yrs.: ask a dentist
Questions?

1-855-210-8802

Active Ingredient

Sodium fluoride 0.243% (0.15% w/v fluoride ion)

Inactive Ingredients

water, sorbitol, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, flavor, cellulose gum, sodium hydroxide, sodium saccharin, carbomer, charcoal powder, sucralose, polysorbate 80, mica, titanium dioxide

Principal Display Panel 116 G Carton

GLEEM

FLUORIDE ANTICAVITY TOOTHPASTE

WHITENING

CHARCOAL POWDER

NET WT 4.1 OZ (116 g)

Structured Label Content

Use

helps protect against cavities

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children under 6 yrs. of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Anticavity toothpaste

Directions
  • adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
    • do not swallow
    • to minimize swallowing use a pea-sized amount in children under 6
    • supervise children's brushing until good habits are established
  • children under 2 yrs.: ask a dentist
Questions?

1-855-210-8802

Active Ingredient (Active ingredient)

Sodium fluoride 0.243% (0.15% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

water, sorbitol, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, flavor, cellulose gum, sodium hydroxide, sodium saccharin, carbomer, charcoal powder, sucralose, polysorbate 80, mica, titanium dioxide

Principal Display Panel 116 G Carton (PRINCIPAL DISPLAY PANEL - 116 g Carton)

GLEEM

FLUORIDE ANTICAVITY TOOTHPASTE

WHITENING

CHARCOAL POWDER

NET WT 4.1 OZ (116 g)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:41.686830 · Updated: 2026-03-14T23:09:36.432892