White Glo Bio-enzyme Kit

White Glo Bio-enzyme Kit
SPL v6
SPL
SPL Set ID f894a841-0df7-470d-8fc2-c9d6ba0edf99
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
Sorbitol Water Hydrated Silica Polyethylene Glycol 400 Sodium Lauryl Sulfate Xylitol Methyl Salicylate Carboxymethylcellulose Sodium, Unspecified Form Sodium Benzoate Sodium Ascorbyl Phosphate .alpha.-tocopherol Acetate Bromelains Papain Menthol

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
Pcakage Labeling:

Inactive Ingredients

sorbitol, water, hydrated silica, PEG-8, sodium lauryl sulfate, xylitol, flavor, cellulose gum, sodium benzoate, sodium ascorbyl phosphate, tocopherol acetate, bromelain, papain, menthol

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
Pcakage Labeling:

Inactive Ingredients (Inactive ingredients)

sorbitol, water, hydrated silica, PEG-8, sodium lauryl sulfate, xylitol, flavor, cellulose gum, sodium benzoate, sodium ascorbyl phosphate, tocopherol acetate, bromelain, papain, menthol

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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