colgate great regular flavor fluoride toothpaste

colgate great regular flavor fluoride toothpaste
SPL v2
SPL
SPL Set ID f89bf259-b738-8229-e053-6394a90a0c59
Route
dental
Published
Effective Date 2019-12-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (49.14 mg)
Inactive Ingredients
sodium lauryl sulfate water glycerin dibasic calcium phosphate dihydrate carboxymethylcellulose sodium, unspecified form sodium pyrophosphate saccharin sodium

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2005-11-05
Purpose

Anticavity

Description

Drug Facts

Medication Information

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
Inactive Ingredients

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

Description

Drug Facts

Principal Display Panel

Use

helps protect against cavities

Section 42229-5

Drug Facts

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.

Active Ingredient

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

Questions Or Comments?

Call toll-free 1-800-468-6502

Structured Label Content

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
Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Use

helps protect against cavities

Section 42229-5 (42229-5)

Drug Facts

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.

Active Ingredient (Active ingredient)

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

Questions Or Comments? (Questions or comments?)

Call toll-free 1-800-468-6502

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:40.227816 · Updated: 2026-03-14T23:03:51.620726