white glo instant white blue foam optical enhancers fluoride anticavity toothpaste value 2 pack and toothbrush

white glo instant white blue foam optical enhancers fluoride anticavity toothpaste value 2 pack and toothbrush
SPL v3
SPL
SPL Set ID 7c15eedb-d4ca-4fc1-8a1e-6f9cad0cc126
Route
dental
Published
Effective Date 2024-06-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (7.6 mg)
Inactive Ingredients
sorbitol hydrated silica water sodium lauryl sulfate polyethylene glycol 400 xylitol sodium benzoate carboxymethylcellulose sodium, unspecified mica fd&c blue no. 1

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-05-30

Purpose

Anticavity toothpaste

Description

Sodium Monofluorophosphate 0.76% (0.1% W/V Fluoride ion).


Medication Information

Warnings

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.

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

Sorbitol, Hydrated Silica, Water (Aqua), Sodium Lauryl Sulfate, Polyethylene Glycol 400, Flavour, Xylitol, Sodium Benzoate, Trisodium Phosphate, Cellulose Gum, Mica, FD&C Blue No. 1.

Description

Sodium Monofluorophosphate 0.76% (0.1% W/V Fluoride ion).

Use

helps protect against cavities

Drug Facts

Active Ingredient

Sodium Monofluorophosphate 0.76% (0.1% W/V Fluoride ion).

Package Labeling:

Questions Or Comments

For customer enquiries, please contact: [email protected]

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

Warnings

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.

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
Inactive Ingredients (Inactive ingredients)

Sorbitol, Hydrated Silica, Water (Aqua), Sodium Lauryl Sulfate, Polyethylene Glycol 400, Flavour, Xylitol, Sodium Benzoate, Trisodium Phosphate, Cellulose Gum, Mica, FD&C Blue No. 1.

Use

helps protect against cavities

Drug Facts

Active Ingredient (Active ingredient)

Sodium Monofluorophosphate 0.76% (0.1% W/V Fluoride ion).

Package Labeling:

Questions Or Comments (Questions or comments)

For customer enquiries, please contact: [email protected]

Keep Out of Reach of Children (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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