Colgate®

Colgate®
SPL v2
SPL
SPL Set ID f87d6f04-507a-47ae-8a66-204cf59261c0
Route
DENTAL
Published
Effective Date 2019-12-11
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 Polyethylene Glycol 600 Sodium Lauryl Sulfate Sodium Pyrophosphate Xanthan Gum Cocamidopropyl Betaine Saccharin Sodium Methylcellulose (100 Mpa.s) Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2008-04-06
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, PEG-12, sodium lauryl sulfate, flavor, tetrasodium pyrophosphate, xanthan gum, cocamidopropyl betaine, sodium saccharin, methylcellulose, FD&C blue no. 1

Principal Display Panel 130 G Bottle Label

WITH WHITENING

MaxFresh®

WITH

MINI

BREATH STRIPS

Colgate®

Anticavity Fluoride Toothpaste

Bursting with

Freshness that

Lasts for Hours!

COOL

MINT

NET WT 4.6 OZ (130 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% (0.14% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

sorbitol, water, hydrated silica, PEG-12, sodium lauryl sulfate, flavor, tetrasodium pyrophosphate, xanthan gum, cocamidopropyl betaine, sodium saccharin, methylcellulose, FD&C blue no. 1

Principal Display Panel 130 G Bottle Label (PRINCIPAL DISPLAY PANEL - 130 g Bottle Label)

WITH WHITENING

MaxFresh®

WITH

MINI

BREATH STRIPS

Colgate®

Anticavity Fluoride Toothpaste

Bursting with

Freshness that

Lasts for Hours!

COOL

MINT

NET WT 4.6 OZ (130 g)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:09.177756 · Updated: 2026-03-14T23:04:38.930408