Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 77e51d6f-c1a2-4650-b3dd-5e4552379e77
Route
DENTAL
Published
Effective Date 2024-11-07
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 Silicon Dioxide Sodium Lauryl Sulfate Carboxymethylcellulose Sodium Sodium Silicate Sodium Pyrophosphate Saccharin Sodium Titanium Dioxide Polyethylene Glycol 400

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-09-16
Description

Sodium Monofluorophosphate - .76% (Total Fluoride Content - 1000 ppm Approx.)

Medication Information

Warnings and Precautions

Keep out of Reach of Children.

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

Indications and Usage

Aids in the prevention of dental cavities

Dosage and Administration

Adults and Children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as instructed by a dentist or doctor.

  • do not swallow
  • instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing use a pea-sized amount)
  • supervise children as necessary until capable of using without supervision

Children under 2 years of age:consult a dentist or doctor

Description

Sodium Monofluorophosphate - .76% (Total Fluoride Content - 1000 ppm Approx.)

Section 50565-1

Keep out of Reach of Children.

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

Section 51727-6

Calcium Carbonate, Treated Water, Sorbitol, Silica, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Sodium Silicate, Tetrasodium Pyrophosphate, Sodium Saccharin, Titanium Dioxide, PEG-8

Section 51945-4

Section 55105-1

Anticavity

Section 55106-9

Sodium Monofluorophosphate - .76%

(Total Fluoride Content - 1000 ppm Approx.)

Structured Label Content

Indications and Usage (34067-9)

Aids in the prevention of dental cavities

Dosage and Administration (34068-7)

Adults and Children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as instructed by a dentist or doctor.

  • do not swallow
  • instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing use a pea-sized amount)
  • 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)

Keep out of Reach of Children.

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

Section 50565-1 (50565-1)

Keep out of Reach of Children.

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

Section 51727-6 (51727-6)

Calcium Carbonate, Treated Water, Sorbitol, Silica, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Sodium Silicate, Tetrasodium Pyrophosphate, Sodium Saccharin, Titanium Dioxide, PEG-8

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anticavity

Section 55106-9 (55106-9)

Sodium Monofluorophosphate - .76%

(Total Fluoride Content - 1000 ppm Approx.)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:24.242129 · Updated: 2026-03-14T23:10:48.259693