Gleem Protection

Gleem Protection
SPL v5
SPL
SPL Set ID c3147bdd-bc55-defa-e053-2995a90adfb5
Route
DENTAL
Published
Effective Date 2018-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.4 mg)
Inactive Ingredients
Stannous Chloride Sucralose Hydrated Silica Sorbitol Sodium Citrate Zinc Citrate Water Sodium Lauryl Sulfate Sodium Gluconate Carrageenan Saccharin Sodium Xanthan Gum Titanium Dioxide Sodium Hydroxide Fd&c Blue No. 1

Identifiers & Packaging

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

Description

Drug Facts

Purpose

Anticavity, antigingivitis toothpaste


Medication Information

Purpose

Anticavity, antigingivitis toothpaste

Description

Drug Facts

Uses
  • aids in the prevention of cavities
  • helps prevent gingivitis
  • helps interfere with the harmful effects of plaque associated with gingivitis
  • helps control plaque bacteria that contribute to the development of gingivitis
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children under 12 yrs. of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Purposes

Anticavity, antigingivitis toothpaste

Directions
  • adults and children 12 yrs. of age & older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.
  • do not swallow
  • children under 12 yrs.: ask a dentist
Questions?

1-855-510-8802

Active Ingredient

Stannous fluoride 0.454% (0.14% w/v fluoride ion)

Other Information
  • products containing stannous fluoride may produce surface staining of the teeth
  • adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist
  • this product is specially formulated to help prevent staining
  • see your dentist regularly
Inactive Ingredients

water, sorbitol, hydrated silica, sodium lauryl sulfate, sodium gluconate, carrageenan, flavor, sodium citrate, xanthan gum, zinc citrate, sodium hydroxide, stannous chloride, sodium saccharin, sucralose, titanium dioxide, blue 1

Principal Display Panel 99 G Tube Carton

GLEEM

FLUORIDE TOOTHPASTE FOR ANTICAVITY AND ANTIGINGIVITIS

PROTECTION

CAVITY PROTECTION

NET WT 4.1 OZ (116 g)


Structured Label Content

Uses
  • aids in the prevention of cavities
  • helps prevent gingivitis
  • helps interfere with the harmful effects of plaque associated with gingivitis
  • helps control plaque bacteria that contribute to the development of gingivitis
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children under 12 yrs. of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Purposes

Anticavity, antigingivitis toothpaste

Directions
  • adults and children 12 yrs. of age & older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.
  • do not swallow
  • children under 12 yrs.: ask a dentist
Questions?

1-855-510-8802

Active Ingredient (Active ingredient)

Stannous fluoride 0.454% (0.14% w/v fluoride ion)

Other Information (Other information)
  • products containing stannous fluoride may produce surface staining of the teeth
  • adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist
  • this product is specially formulated to help prevent staining
  • see your dentist regularly
Inactive Ingredients (Inactive ingredients)

water, sorbitol, hydrated silica, sodium lauryl sulfate, sodium gluconate, carrageenan, flavor, sodium citrate, xanthan gum, zinc citrate, sodium hydroxide, stannous chloride, sodium saccharin, sucralose, titanium dioxide, blue 1

Principal Display Panel 99 G Tube Carton (PRINCIPAL DISPLAY PANEL - 99 g Tube Carton)

GLEEM

FLUORIDE TOOTHPASTE FOR ANTICAVITY AND ANTIGINGIVITIS

PROTECTION

CAVITY PROTECTION

NET WT 4.1 OZ (116 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)