White Glo Toothpaste Mouthwash Protection + Toothbrush

White Glo Toothpaste Mouthwash Protection + Toothbrush
SPL v5
SPL
SPL Set ID ce4f0f8f-46f1-b4e6-e053-2a95a90af6c6
Route
DENTAL
Published
Effective Date 2021-10-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1 mg)
Inactive Ingredients
Calcium Carbonate Water Sorbitol Glycerin Silicon Dioxide Alcohol Sodium Lauryl Sulfate Sodium Phosphate, Tribasic, Anhydrous Carrageenan Carboxymethylcellulose Sodium, Unspecified Hydroxyethyl Cellulose, Unspecified Saccharin Sodium Sodium Silicate Thymol Rosa Canina Fruit Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-11-01

Description

Sodium monofluorophosphate 0.76%(0.1% W/V fluoride ion)

Purpose

Anticavity toothpaste


Medication Information

Purpose

Anticavity toothpaste

Description

Sodium monofluorophosphate 0.76%(0.1% W/V fluoride ion)

Use

helps pretect against cavities

Directions
 Adults and children 2 years of age & older:   Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
 Children under 6 years of age:   Instruct 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 monofluorophosphate 0.76%(0.1% W/V fluoride ion)

Other Information
  • Store in a cool place, below 86°F, away from heat
  • Do not use if quality seal is broken or missing
Package Labeling:

Inactive Ingredients

Calcium Carbonate, Water, Sorbitol, Glycerin, Silica, Alcohol, Sodium Lauryl Sulfate, Flavor, Carrageenan, Cellulose Gum, Hydroxyethylcellulose, Sodium Saccharin, Sodium Silicate, Trisodium Phosphate, Thymol, Rosa Canina Fruit Oil

Questions Or Comments

For customer enquiries, please contact:[email protected] White Glo USA INC. 25 Suffolk Court, Hauppauge, NY, 11788 USA. www.whiteglo.com

Keep Out of Reach of Children

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


Structured Label Content

Use

helps pretect against cavities

Purpose

Anticavity toothpaste

Directions
 Adults and children 2 years of age & older:   Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
 Children under 6 years of age:   Instruct 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 monofluorophosphate 0.76%(0.1% W/V fluoride ion)

Other Information (Other information)
  • Store in a cool place, below 86°F, away from heat
  • Do not use if quality seal is broken or missing
Package Labeling:

Inactive Ingredients (Inactive ingredients)

Calcium Carbonate, Water, Sorbitol, Glycerin, Silica, Alcohol, Sodium Lauryl Sulfate, Flavor, Carrageenan, Cellulose Gum, Hydroxyethylcellulose, Sodium Saccharin, Sodium Silicate, Trisodium Phosphate, Thymol, Rosa Canina Fruit Oil

Questions Or Comments (Questions or comments)

For customer enquiries, please contact:[email protected] White Glo USA INC. 25 Suffolk Court, Hauppauge, NY, 11788 USA. www.whiteglo.com

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 rightaway. under 6 years of age.


Advanced Ingredient Data


Raw Label Data

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