Colgate®

Colgate®
SPL v16
SPL
SPL Set ID d142e43f-415a-41c5-a7db-8b18a039a323
Route
DENTAL
Published
Effective Date 2019-04-09
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 Carboxymethylcellulose Sodium, Unspecified Sodium Pyrophosphate Cocamidopropyl Betaine Saccharin Sodium Powdered Cellulose Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2011-08-01 Until 2024-12-31
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% (0.15% w/v fluoride ion)

Inactive Ingredients

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

Principal Display Panel 170 G Tube Carton

Colgate®

Anticavity

Fluoride Toothpaste

NET WT 6.0 OZ (170 g)

COOL MINT

Max Fresh ®

with WHITENING

BREATH STRIPS

FRESHNESS THAT LASTS FOR HOURS!

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% (0.15% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel 170 G Tube Carton (PRINCIPAL DISPLAY PANEL - 170 g Tube Carton)

Colgate®

Anticavity

Fluoride Toothpaste

NET WT 6.0 OZ (170 g)

COOL MINT

Max Fresh ®

with WHITENING

BREATH STRIPS

FRESHNESS THAT LASTS FOR HOURS!

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:33.139359 · Updated: 2026-03-14T23:05:22.628914