crest cavity protection

crest cavity protection
SPL v1
SPL
SPL Set ID 23851360-e30e-dd97-e063-6394a90a5474
Route
dental
Published
Effective Date 2019-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (1.5 mg)
Inactive Ingredients
sodium phosphate, tribasic, anhydrous carboxypolymethylene sodium lauryl sulfate sodium phosphate titanium dioxide fd&c blue no. 1 saccharin sodium carboxymethylcellulose sodium, unspecified form sorbitol water hydrated silica

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
otc monograph drug active Since 1984-08-02
Purpose

Anticavity toothpaste

Description

Drug Facts

Medication Information

Purpose

Anticavity toothpaste

Directions
  • adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
    • do not swallow
    • to minimize swallowing use a pea-sized amount in children under 6
    • supervise children's brushing until good habits are established
  • children under 2 yrs.: ask a dentist
Inactive Ingredients

sorbitol, water, hydrated silica, sodium lauryl sulfate, trisodium phosphate, flavor, cellulose gum, sodium phosphate, carbomer, sodium saccharin, titanium dioxide, blue 1

Description

Drug Facts

Principal Display Panel

Questions?

1-800-492-7378

Use

helps protect teeth and roots against cavities

Section 42229-5

Drug Facts

Section 50565-1

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

Active Ingredient

Sodium fluoride 0.243% (0.15% w/v fluoride ion)

Structured Label Content

Purpose

Anticavity toothpaste

Directions
  • adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
    • do not swallow
    • to minimize swallowing use a pea-sized amount in children under 6
    • supervise children's brushing until good habits are established
  • children under 2 yrs.: ask a dentist
Inactive Ingredients (Inactive ingredients)

sorbitol, water, hydrated silica, sodium lauryl sulfate, trisodium phosphate, flavor, cellulose gum, sodium phosphate, carbomer, sodium saccharin, titanium dioxide, blue 1

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Questions?

1-800-492-7378

Use

helps protect teeth and roots against cavities

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Active Ingredient (Active ingredient)

Sodium fluoride 0.243% (0.15% w/v fluoride ion)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:03:39.368400 · Updated: 2026-03-14T23:03:50.462651