Colgate®

Colgate®
SPL v1
SPL
SPL Set ID 0ffbb3a9-7bfa-4f6a-aef3-fde327a410c9
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

Identifiers & Packaging

Pill Appearance
Color: blue
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, Flavor, Sodium Lauryl Sulfate, PEG-12, Sodium Saccharin, Cellulose Gum, Glycerin, Cocamidopropyl Betaine, Hydroxypropyl Methylcellulose, Blue 1, Titanium Dioxide.

Principal Display Panel 178 G Tube Carton

Colgate®

Anticavity

Fluoride Toothpaste

MaxFresh®

FRESHNESS POWERED BY

ULTRAFREEZE

10X LONGER LASTING COOL FOR FRESH BREATH

KNOCKOUT®

FIGHTS BAD BREATH

& FOOD AFTERTASTES*

Mint Fusion®

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, Flavor, Sodium Lauryl Sulfate, PEG-12, Sodium Saccharin, Cellulose Gum, Glycerin, Cocamidopropyl Betaine, Hydroxypropyl Methylcellulose, Blue 1, Titanium Dioxide.

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

KNOCKOUT®

FIGHTS BAD BREATH

& FOOD AFTERTASTES*

Mint Fusion®

WITH BREATH STRIPS

NET WT 6.3 OZ (178g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)