White Glo Professional Choice Kit

White Glo Professional Choice Kit
SPL v5
SPL
SPL Set ID 13314c9a-de93-4f54-b703-b5cebdf1e6aa
Route
DENTAL
Published
Effective Date 2020-02-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (7.6 mg)
Inactive Ingredients
Calcium Carbonate Water Sorbitol Glycerin Hydrated Silica Sodium Lauryl Sulfate Methyl Salicylate Saccharin Sodium Sodium Silicate Sodium Phosphate, Tribasic, Anhydrous Carboxymethylcellulose Sodium, Unspecified Form Hydroxyethyl Cellulose, Unspecified Rosa Canina Fruit Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-02-15

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 protect 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.

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

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, hydrated silica, sodium lauryl sulfate, flavor, sodium saccharin, sodium silicate, trisodium phosphate, cellulose gum, hydroxyethylcellulose, rosa canina (rose hip) 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 Under 6 Years of Age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Use

helps protect 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.

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

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, hydrated silica, sodium lauryl sulfate, flavor, sodium saccharin, sodium silicate, trisodium phosphate, cellulose gum, hydroxyethylcellulose, rosa canina (rose hip) 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 Under 6 Years of Age. (Keep out of reach of children under 6 years of age.)

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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