Colgate Ultra Brite®

SPL v2

SPL

SPL Set ID 2b123d70-4f7d-41b0-b48f-711999e97ee0

Route

DENTAL

Published

Effective Date 2019-12-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (1.1 mg)

Inactive Ingredients

Glycerin Hydrated Silica Water Sodium Bicarbonate Polyethylene Glycol 600 Sodium Lauryl Sulfate Sodium Hydroxide Carboxymethylcellulose Sodium, Unspecified Carrageenan Saccharin Sodium Calcium Peroxide Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2011-12-01

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.

Section 50569-3

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 monofluorophosphate 0.76% (0.14% w/v fluoride ion)

Inactive Ingredients

glycerin, hydrated silica, water, sodium bicarbonate, PEG-12, sodium lauryl sulfate, flavor, sodium hydroxide, cellulose gum, carrageenan, sodium saccharin, calcium peroxide, titanium dioxide

Principal Display Panel 170 G Tube Carton

COOL MINT

Ultra brite ^®

ANTICAVITY FLUORIDE TOOTHPASTE

NET WT 6.0 OZ (170 g)

DEEP CLEANS TEETH

Baking Soda

& Peroxide

Whitening

TOOTHPASTE

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.

Section 50569-3 (50569-3)

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 monofluorophosphate 0.76% (0.14% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

glycerin, hydrated silica, water, sodium bicarbonate, PEG-12, sodium lauryl sulfate, flavor, sodium hydroxide, cellulose gum, carrageenan, sodium saccharin, calcium peroxide, titanium dioxide

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

COOL MINT

Ultra brite ^®

ANTICAVITY FLUORIDE TOOTHPASTE

NET WT 6.0 OZ (170 g)

DEEP CLEANS TEETH

Baking Soda

& Peroxide

Whitening

TOOTHPASTE

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Use": "helps protect against cavities", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children under 6 years of age.", "50569-3": "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": "Sodium monofluorophosphate 0.76% (0.14% w/v fluoride ion)", "Inactive ingredients": "glycerin, hydrated silica, water, sodium bicarbonate, PEG-12, sodium lauryl sulfate, flavor, sodium hydroxide, cellulose gum, carrageenan, sodium saccharin, calcium peroxide, titanium dioxide", "PRINCIPAL DISPLAY PANEL - 170 g Tube Carton": "COOL MINT Ultra brite ® ANTICAVITY FLUORIDE TOOTHPASTE NET WT 6.0 OZ (170 g) DEEP CLEANS TEETH Baking Soda & Peroxide Whitening TOOTHPASTE"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:54.053401 · Updated: 2026-03-14T23:04:13.637753