Anti-cavity Fluoride Toothpaste

Anti-cavity Fluoride Toothpaste
SPL v1
SPL
SPL Set ID 2e236fb0-6c78-4546-822e-f97b11af5223
Route
ORAL
Published
Effective Date 2017-06-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (7.6 mg)
Inactive Ingredients
Calcium Carbonate Methylparaben Polyethylene Glycol 400 Propylparaben Carboxymethylcellulose Sodium, Unspecified Form Sodium Lauryl Sulfate Saccharin Sodium Sodium Silicate Sorbitol Sodium Pyrophosphate Titanium Dioxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-06-21
Description

Active Ingredient Sodium Monofluorophosphate  0.76% (Total Fluoride Content - 1000 ppm approx.)

Medication Information

Warnings and Precautions

Warning

Indications and Usage

Uses

  • regular brushing with flouride toothpaste helps protect teeth againts builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets or contact.
  • aids in the prevention of dental cavities.
Dosage and Administration

Directions

  • adults and children of 6 years and older: brush teeth thoroughly, after meals or at least twice a day, or as directed by a dentist.
  • do not swallow.
  • to minimize swallowing, use pea-sized amount in children under 6 years old.
  • supervise child's brushing until good habits are established.
  • children under 2 years: ask a dentist before use.
Description

Active Ingredient Sodium Monofluorophosphate  0.76% (Total Fluoride Content - 1000 ppm approx.)

Section 42229-5

Other information

  • store in a cool, dry place.
Section 50565-1

Keep out of reach of children under 6 years of age

  • If accidentally swallowed get medical help or contact a Poison Control Center right away.
Section 50566-9

Stop and ask a dentist

  • if the problem persists or worsens.

Sensitivity teeth may indicate a serious problem that may need prompt care by a dentist.

Section 50567-7

When using this product

  • if pain\ sensitivity still persists after 4 weeks of use, please visit your dentist.
Section 51727-6

Inactive Ingredients

calcium carbonate, flavor, methylparaben, poly ethylene glycol 400, precipited silica, propylparaben, sodium carboxymethyl cellulose, sodium lauryl sulfate, sodium saccharin, sodium silicate, sorbitol, tetra sodium pyrophosphate, titanium dioxide, water.

Section 51945-4

PRINCIPAL DISPLAY PANEL

ANTI-CAVITY FLUORIDE TOOTHPASTE

Section 55105-1

Purpose

Anticavity toothpaste

Section 55106-9

Active Ingredient

Sodium Monofluorophosphate  0.76%

(Total Fluoride Content - 1000 ppm approx.)

Structured Label Content

Indications and Usage (34067-9)

Uses

  • regular brushing with flouride toothpaste helps protect teeth againts builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets or contact.
  • aids in the prevention of dental cavities.
Dosage and Administration (34068-7)

Directions

  • adults and children of 6 years and older: brush teeth thoroughly, after meals or at least twice a day, or as directed by a dentist.
  • do not swallow.
  • to minimize swallowing, use pea-sized amount in children under 6 years old.
  • supervise child's brushing until good habits are established.
  • children under 2 years: ask a dentist before use.
Warnings and Precautions (34071-1)

Warning

Section 42229-5 (42229-5)

Other information

  • store in a cool, dry place.
Section 50565-1 (50565-1)

Keep out of reach of children under 6 years of age

  • If accidentally swallowed get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)

Stop and ask a dentist

  • if the problem persists or worsens.

Sensitivity teeth may indicate a serious problem that may need prompt care by a dentist.

Section 50567-7 (50567-7)

When using this product

  • if pain\ sensitivity still persists after 4 weeks of use, please visit your dentist.
Section 51727-6 (51727-6)

Inactive Ingredients

calcium carbonate, flavor, methylparaben, poly ethylene glycol 400, precipited silica, propylparaben, sodium carboxymethyl cellulose, sodium lauryl sulfate, sodium saccharin, sodium silicate, sorbitol, tetra sodium pyrophosphate, titanium dioxide, water.

Section 51945-4 (51945-4)

PRINCIPAL DISPLAY PANEL

ANTI-CAVITY FLUORIDE TOOTHPASTE

Section 55105-1 (55105-1)

Purpose

Anticavity toothpaste

Section 55106-9 (55106-9)

Active Ingredient

Sodium Monofluorophosphate  0.76%

(Total Fluoride Content - 1000 ppm approx.)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:22.259164 · Updated: 2026-03-14T22:54:46.340416