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
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

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

Description

Drug Facts

Questions?

1-800-468-6502

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.

Active Ingredient

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

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

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)

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

Questions?

1-800-468-6502

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.

Active Ingredient (Active ingredient)

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

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

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