Colgate®

Colgate®
SPL v4
SPL
SPL Set ID e4d37ef1-1966-410b-9996-df9ba02aeceb
Route
DENTAL
Published
Effective Date 2019-04-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.1 mg)
Inactive Ingredients
Sorbitol Water Glycerin Hydrated Silica Sodium Lauryl Sulfate Cocamidopropyl Betaine Sodium Pyrophosphate Saccharin Sodium Titanium Dioxide Carboxymethylcellulose Sodium, Unspecified Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-07-26
Description

Drug Facts

Purpose

Anticavity

Medication Information

Purpose

Anticavity

Description

Drug Facts

Use

aids in the prevention of cavities

Section 42229-5

Drug Facts

Section 50565-1

Keep out of the 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?

Call toll-free 1-800-468-6502

Active Ingredient

Sodium fluoride 0.24% (0.14% w/v fluoride ion)

Inactive Ingredients

water, sorbitol, hydrated silica, glycerin, sodium lauryl sulfate, flavor, tetrasodium pyrophosphate, sodium saccharin, cocamidopropyl betaine, cellulose gum, xanthan gum, titanium dioxide

Principal Display Panel 130 G Bottle Label

2 in 1

Toothpaste

& Mouthwash

Colgate ®

Fluoride Toothpaste

Cleans Teeth & Freshens Breath

Whitening

with Stain Lifters

NET WT 4.6 OZ (130 g)

LIQUID GEL

Structured Label Content

Use

aids in the prevention of cavities

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of the 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?

Call toll-free 1-800-468-6502

Active Ingredient (Active ingredient)

Sodium fluoride 0.24% (0.14% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

water, sorbitol, hydrated silica, glycerin, sodium lauryl sulfate, flavor, tetrasodium pyrophosphate, sodium saccharin, cocamidopropyl betaine, cellulose gum, xanthan gum, titanium dioxide

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

2 in 1

Toothpaste

& Mouthwash

Colgate ®

Fluoride Toothpaste

Cleans Teeth & Freshens Breath

Whitening

with Stain Lifters

NET WT 4.6 OZ (130 g)

LIQUID GEL

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:54.913830 · Updated: 2026-03-14T23:04:15.032207