SPL v4
SPL
SPL Set ID 663b00d2-2a68-02a8-e053-2a91aa0a2c73
Route
ORAL
Published
Effective Date 2018-02-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.76 g)
Inactive Ingredients
Sodium Sulfate Sodium Cocoyl Glutamate Glycerin Water Silicon Dioxide Xylitol Aloe Vera Leaf Bambusa Arundinacea Stem Citrus Maxima Seed Perilla Frutescens Seed Stevia Rebaudiuna Leaf Ubidecarenone Magnesium Silicate Sea Salt Calcium Carbonate Carboxymethylcellulose Sodium Dimethyl Sulfone Sodium Bicarbonate .alpha.-tocopherol Acetate Peppermint

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-10-04
Description

Sodium Monofluorophosphate 0.76%

Medication Information

Warnings and Precautions

Avoid storing at high temperatures (greater than 100°F). Protect from freezing. If you accidentally swalow more than used for brushing, seek professional assistance or contact Poison Control immediately.

Indications and Usage





use: Prevention of cavities

Dosage and Administration

Prevent plaque and tartar buildup with regular drushing. Adults and children 2 years of age or older should brush teeth after each meal (or at least twice a day, or as directed by a dentist or physician). Children under 6: Should use only a pea sized amount of paste and be supervised as necessary. Children under 2, check with a dentist or physician before using.

Description

Sodium Monofluorophosphate 0.76%

Section 50565-1

Keep out of reach of children under 6 years of age.If you accidentally swallow more than used for brushing, get medical help or contact Poison Control Center immediately.

Section 51727-6

Glycerin, Aqua (Water), Silica, Sodium Cocoyl Glutamate, Xylitol, Mentha Piperita (Peppermint) Oil, Aloe Barbadensis Leaf Juice (1), Bambusa Arundinacea Stem Powder, Citrus Grandis (Grapefruit) Seed Extract, Perilla Ocymoides Seed Extract, Stevia Rebaudiana Leaf/Steam Extract, Calcium Carbonate, Cellulose Gum, Dimethyl Sulfone, Sea Salt, Tocopheryl Acetate, Sodium Bicarbonate, Sodium Magnesium Silicate, Sodium Sulfatre, Ubiquinone (2).

(1) Certified Organic Ingredients

(2) Coenzyme Q10

Section 51945-4

Section 55105-1

Anticavity

Section 55106-9





Sodium Monofluorophosphate 0.76%

Structured Label Content

Indications and Usage (34067-9)





use: Prevention of cavities

Dosage and Administration (34068-7)

Prevent plaque and tartar buildup with regular drushing. Adults and children 2 years of age or older should brush teeth after each meal (or at least twice a day, or as directed by a dentist or physician). Children under 6: Should use only a pea sized amount of paste and be supervised as necessary. Children under 2, check with a dentist or physician before using.

Warnings and Precautions (34071-1)

Avoid storing at high temperatures (greater than 100°F). Protect from freezing. If you accidentally swalow more than used for brushing, seek professional assistance or contact Poison Control immediately.

Section 50565-1 (50565-1)

Keep out of reach of children under 6 years of age.If you accidentally swallow more than used for brushing, get medical help or contact Poison Control Center immediately.

Section 51727-6 (51727-6)

Glycerin, Aqua (Water), Silica, Sodium Cocoyl Glutamate, Xylitol, Mentha Piperita (Peppermint) Oil, Aloe Barbadensis Leaf Juice (1), Bambusa Arundinacea Stem Powder, Citrus Grandis (Grapefruit) Seed Extract, Perilla Ocymoides Seed Extract, Stevia Rebaudiana Leaf/Steam Extract, Calcium Carbonate, Cellulose Gum, Dimethyl Sulfone, Sea Salt, Tocopheryl Acetate, Sodium Bicarbonate, Sodium Magnesium Silicate, Sodium Sulfatre, Ubiquinone (2).

(1) Certified Organic Ingredients

(2) Coenzyme Q10

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anticavity

Section 55106-9 (55106-9)





Sodium Monofluorophosphate 0.76%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:30.623835 · Updated: 2026-03-14T22:59:31.191887