colgate®

colgate®
SPL v1
SPL
SPL Set ID de3674f4-3ce6-47d5-8391-6ad6789d68d9
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 activated charcoal fd&c red no. 40

Identifiers & Packaging

Pill Appearance
Color: black
Marketing Status
otc monograph drug active Since 2025-02-03

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, Flavor, Sodium Lauryl Sulfate, PEG-12, Sodium Saccharin, Cellulose Gum, Glycerin, Cocamidopropyl Betaine, Hydroxypropyl Methylcellulose, Charcoal Powder, Blue 1, Red 40, Titanium Dioxide, 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% (0.14% w/v fluoride ion)

Principal Display Panel 178 G Tube Carton

Colgate®

Anticavity Fluoride Toothpaste

MaxFresh®

FRESHNESS POWERED BY

ULTRAFREEZE

10X LONGER LASTING COOL FOR FRESH BREATH

+CHARCOAL

Charcoal Mint

WITH BREATH STRIPS

NET WT 6.3 OZ (178 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, Flavor, Sodium Lauryl Sulfate, PEG-12, Sodium Saccharin, Cellulose Gum, Glycerin, Cocamidopropyl Betaine, Hydroxypropyl Methylcellulose, Charcoal Powder, Blue 1, Red 40, Titanium Dioxide, 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% (0.14% w/v fluoride ion)

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

+CHARCOAL

Charcoal Mint

WITH BREATH STRIPS

NET WT 6.3 OZ (178 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)