Pro Care Flouride Toothpaste

Pro Care Flouride Toothpaste
SPL v1
SPL
SPL Set ID ac8a9fd0-5447-2ade-e053-2a95a90a36d9
Route
DENTAL
Published
Effective Date 2020-08-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (2.1 mg)
Inactive Ingredients
Carboxymethylcellulose Sodium, Unspecified Hydrated Silica Methyl Salicylate Mica Polyethylene Glycol 1600 Propolis Wax Sodium Chloride Sodium Lauryl Sulfate Saccharin Sodium Sorbitol Troxerutin Water Xylitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-08-05

Description

Sodium fluoride 0.21%

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Sodium fluoride 0.21%

Use

aids in the prevention of dental cavities

Directions

Adults and children 2 years of age and older. Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentis or doctor.

Children under 6 years old of age. Intruct in good brushing and rinsing habits ( to minimize swallowing) Supevise children as necessary until capable of using without supervison.

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

Drugs Facts:

Active Ingredient

Sodium fluoride 0.21%

Other Information

Use at least 0.04 oz (1 g) of toothpaste. Close the cap after usage. Keep away from direct sunlight for a long time.

Package Labeling:

Inactive Ingredients

Cellulose Gum, Hydrate Silica, Flavor, Mica, Organic psidium guajava fruit, PEG-32, Propolis Extract, Sodium Chloride, Sodium Lauryl Sulfate, Sodium Sarcharin, Sorbitol, Troxerutin, Water, Xylitol.

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

aids in the prevention of dental cavities

Purpose

Anticavity

Directions

Adults and children 2 years of age and older. Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentis or doctor.

Children under 6 years old of age. Intruct in good brushing and rinsing habits ( to minimize swallowing) Supevise children as necessary until capable of using without supervison.

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

Drugs Facts:

Active Ingredient (Active ingredient)

Sodium fluoride 0.21%

Other Information (Other information)

Use at least 0.04 oz (1 g) of toothpaste. Close the cap after usage. Keep away from direct sunlight for a long time.

Package Labeling:

Inactive Ingredients

Cellulose Gum, Hydrate Silica, Flavor, Mica, Organic psidium guajava fruit, PEG-32, Propolis Extract, Sodium Chloride, Sodium Lauryl Sulfate, Sodium Sarcharin, Sorbitol, Troxerutin, Water, Xylitol.

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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