Anticavity Toothpaste Kit

Anticavity Toothpaste Kit
SPL v3
SPL
SPL Set ID 8a270893-25ad-98b7-e053-2a95a90a980e
Route
DENTAL
Published
Effective Date 2019-06-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (7.6 mg)
Inactive Ingredients
Calcium Phosphate, Dibasic, Dihydrate Water Sorbitol Sodium Lauryl Sulfate Carboxymethylcellulose Sodium Sodium Pyrophosphate Saccharin Sodium Limonene, (+/-)-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-06-14
Description

Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

Purpose

Anticavity

Medication Information

Purpose

Anticavity

Description

Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

Use

helps protect against cavities

Section 50565-1

Keep out of the reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions
adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 years ask a dentist or physician
Active Ingredient

Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

Inactive Ingredients

dicalcium phosphate dihydrate, water, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, sodium saccharin

Questions Or Comments?

Call toll-free 1-800-468-6502

Principal Display Panel 5g Tube Label

Structured Label Content

Use

helps protect against cavities

Section 50565-1 (50565-1)

Keep out of the reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Anticavity

Directions
adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 years ask a dentist or physician
Active Ingredient (Active ingredient)

Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

dicalcium phosphate dihydrate, water, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, sodium saccharin

Questions Or Comments? (Questions or comments?)

Call toll-free 1-800-468-6502

Principal Display Panel 5g Tube Label (PRINCIPAL DISPLAY PANEL - 5g Tube Label)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:59:13.220453 · Updated: 2026-03-14T22:59:07.764303