Colgate®

Colgate®
SPL v3
SPL
SPL Set ID ae679038-396e-4335-9678-48126c430a0f
Route
DENTAL
Published
Effective Date 2019-07-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.1 mg)
Inactive Ingredients
Sorbitol Water Hydrated Silica Sodium Lauryl Sulfate Polyethylene Glycol 600 Carboxymethylcellulose Sodium, Unspecified Saccharin Sodium Fd&c Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-08-05
Description

Drug Facts

Purpose

Anticavity

Medication Information

Purpose

Anticavity

Description

Drug Facts

Use

helps protect against cavities

Section 42229-5

Drug Facts

Section 50565-1

Keep out of 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
Questions?

1-800-468-6502

Active Ingredient

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Inactive Ingredients

Sorbitol, Water, Hydrated Silica, Sodium Lauryl Sulfate, Flavor, PEG-12, Cellulose Gum, Sodium Saccharin, Blue 1, Yellow 5.

Principal Display Panel 113 G Tube Label

Colgate®

ages

8+

Fluoride

Toothpaste

FRESH MINT flavor

Clinically Proven

Cavity and Enamel

Protection

Toothpaste

NET WT

4.0 OZ

(113 g)

Structured Label Content

Use

helps protect against cavities

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of 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
Questions?

1-800-468-6502

Active Ingredient (Active ingredient)

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

Sorbitol, Water, Hydrated Silica, Sodium Lauryl Sulfate, Flavor, PEG-12, Cellulose Gum, Sodium Saccharin, Blue 1, Yellow 5.

Principal Display Panel 113 G Tube Label (PRINCIPAL DISPLAY PANEL - 113 g Tube Label)

Colgate®

ages

8+

Fluoride

Toothpaste

FRESH MINT flavor

Clinically Proven

Cavity and Enamel

Protection

Toothpaste

NET WT

4.0 OZ

(113 g)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:03:54.107913 · Updated: 2026-03-14T23:04:15.032207