Colgate®

Colgate®
SPL v1
SPL
SPL Set ID eabc263f-92fc-21a0-b571-c8328bc953d3
Route
DENTAL
Published
Effective Date 2025-01-22
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 Glycerin Cocamidopropyl Betaine Saccharin Sodium Hypromellose, Unspecified Fd&c Blue No. 1 Titanium Dioxide Fd&c Yellow No. 5

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-03

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% (0.14% w/v fluoride ion)

Inactive Ingredients

Sorbitol, Water, Hydrated Silica, Sodium Lauryl Sulfate, Flavor, PEG-12, Cellulose Gum, Glycerin, Cocamidopropyl Betaine, Sodium Saccharin, Hydroxypropyl Methylcellulose, Blue 1, Titanium Dioxide, Yellow 5.

Principal Display Panel 178 G Tube Carton

Colgate®

Anticavity Fluoride Toothpaste

MaxFresh®

FRESHNESS POWERED BY

ULTRAFREEZE

10X LONGER LASTING COOL FOR FRESH BREATH

Clean Mint

WITH BREATH STRIPS

NET WT 6.3 OZ (178g)


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% (0.14% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

Sorbitol, Water, Hydrated Silica, Sodium Lauryl Sulfate, Flavor, PEG-12, Cellulose Gum, Glycerin, Cocamidopropyl Betaine, Sodium Saccharin, Hydroxypropyl Methylcellulose, Blue 1, Titanium Dioxide, Yellow 5.

Principal Display Panel 178 G Tube Carton (PRINCIPAL DISPLAY PANEL - 178 g Tube Carton)

Colgate®

Anticavity Fluoride Toothpaste

MaxFresh®

FRESHNESS POWERED BY

ULTRAFREEZE

10X LONGER LASTING COOL FOR FRESH BREATH

Clean Mint

WITH BREATH STRIPS

NET WT 6.3 OZ (178g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)