Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 4d24da8e-1ea1-20ca-e054-00144ff88e88
Route
DENTAL
Published
Effective Date 2017-04-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (7.6 mg)
Inactive Ingredients
Potassium Sorbate Calcium Carbonate Anhydrous Dibasic Calcium Phosphate Carboxymethylcellulose Sodium Sodium Silicate Sodium Lauryl Sulfate Glycerin Aluminum Hydroxide Hydrated Silica Fd&c Blue No. 1 Sorbitan Monooleate Saccharin Sodium Sorbitol Titanium Dioxide Water Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-03-31

Description

Sodium monofluorophosphate 0.76% (Total fluoride content-1000 ppm approx.)

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Sodium monofluorophosphate 0.76% (Total fluoride content-1000 ppm approx.)

Use

regular brushing with fluoride tothpaste helps protect against cavities

Warnings

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately

Directions

adults and children 2 yrs and older brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician. children under 6 yrs to minimize swallowing use a pea-sized amount and brushing until good habits are established. children under 2 years: ask a dentist or physician

Package Label

Active Ingredient

Sodium monofluorophosphate 0.76% (Total fluoride content-1000 ppm approx.)

Inactive Ingredients

calcium carbonate, calcium hydrogen phosphate, carboxymethyl cellulose, FDC Blue 1, flavor, glycerin, hydrated alumina, hydrated silica, potassium sorbate, sodium lauryl sulfate, sodium saccharin, sorbitan monooleate, sorbitol, titanium dioxide, water, xanthan gum

Keep Out of the Reach of Children

under 6 years of age


Structured Label Content

Use

regular brushing with fluoride tothpaste helps protect against cavities

Purpose

Anticavity

Warnings

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately

Directions

adults and children 2 yrs and older brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician. children under 6 yrs to minimize swallowing use a pea-sized amount and brushing until good habits are established. children under 2 years: ask a dentist or physician

Package Label

Active Ingredient

Sodium monofluorophosphate 0.76% (Total fluoride content-1000 ppm approx.)

Inactive Ingredients (Inactive ingredients)

calcium carbonate, calcium hydrogen phosphate, carboxymethyl cellulose, FDC Blue 1, flavor, glycerin, hydrated alumina, hydrated silica, potassium sorbate, sodium lauryl sulfate, sodium saccharin, sorbitan monooleate, sorbitol, titanium dioxide, water, xanthan gum

Keep Out of the Reach of Children (Keep out of the reach of children)

under 6 years of age


Advanced Ingredient Data


Raw Label Data

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