SPL v1
SPL
SPL Set ID 42824602-9b12-449d-9888-ade5a97ce129
Route
DENTAL
Published
Effective Date 2017-06-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.10 g)
Inactive Ingredients
Water Glycerin Sorbitol Carboxymethylcellulose Sodium Sodium Lauryl Sulfate Polyethylene Glycol 1000 Hydrated Silica Saccharin Sodium Xanthan Gum Methylisothiazolinone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-06-03

Description

Active Ingredient: Sodium Fluoride (0.243%)


Medication Information

Warnings and Precautions

If more than used for brushing is accidentally swallowed, get medical help or contact a poison control center immediately.

Indications and Usage

Uses: Aids in the prevention of dental cavities

Dosage and Administration

Adults and children of two years of age and older: Brush teeth thoroughly, perferrably after each meal or at least twice a day, or as directed by a dentist or a doctor. Instruct children under six years of age in good brushing and rinsing habit (to minimize swollowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: consult a dentist or doctor.

Description

Active Ingredient: Sodium Fluoride (0.243%)

Section 50565-1

Keep out of reach of children under six years of age

Section 51727-6

Sorbitol, Hydrated Silica, Glycerin, Purified Water, Polyethylene Glycol, Sodium Lauryl Sulfate,  Carboxymethylcellulose Sodium, Flavor, Xanthan Gum, Saccharin Sodium, Methylisothiazolinone

Section 51945-4

Section 55105-1

Purpose: Anticavity

Section 55106-9

Active Ingredient: Sodium Fluoride (0.243%)


Structured Label Content

Indications and Usage (34067-9)

Uses: Aids in the prevention of dental cavities

Dosage and Administration (34068-7)

Adults and children of two years of age and older: Brush teeth thoroughly, perferrably after each meal or at least twice a day, or as directed by a dentist or a doctor. Instruct children under six years of age in good brushing and rinsing habit (to minimize swollowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: consult a dentist or doctor.

Warnings and Precautions (34071-1)

If more than used for brushing is accidentally swallowed, get medical help or contact a poison control center immediately.

Section 50565-1 (50565-1)

Keep out of reach of children under six years of age

Section 51727-6 (51727-6)

Sorbitol, Hydrated Silica, Glycerin, Purified Water, Polyethylene Glycol, Sodium Lauryl Sulfate,  Carboxymethylcellulose Sodium, Flavor, Xanthan Gum, Saccharin Sodium, Methylisothiazolinone

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: Anticavity

Section 55106-9 (55106-9)

Active Ingredient: Sodium Fluoride (0.243%)


Advanced Ingredient Data


Raw Label Data

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