crest cavity protection cool mint

crest cavity protection cool mint
SPL v4
SPL
SPL Set ID dba7a572-a2f0-4c95-b2a7-cf7301e8ca9d
Route
dental
Published
Effective Date 2024-06-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
otc monograph drug active Since 1995-06-16
Purpose

Anticavity toothpaste

How Supplied

Product: 50090-6233 NDC: 50090-6233-0 161 g in a TUBE / 24 in a CASE

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, cellulose gum, flavor, sodium phosphate, sodium saccharin, carbomer, blue 1

How Supplied

Product: 50090-6233

NDC: 50090-6233-0 161 g in a TUBE / 24 in a CASE

Description

Drug Facts

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.

Sodium Fluoride
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, cellulose gum, flavor, sodium phosphate, sodium saccharin, carbomer, blue 1

How Supplied (HOW SUPPLIED)

Product: 50090-6233

NDC: 50090-6233-0 161 g in a TUBE / 24 in a CASE

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.

Sodium Fluoride
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

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Source: dailymed · Ingested: 2026-02-15T12:03:09.532095 · Updated: 2026-03-14T23:03:04.544899