colgate®

colgate®
SPL v5
SPL
SPL Set ID ed20cf9d-6162-4337-bb0b-1a6a6e9e1dc3
Route
dental
Published
Effective Date 2019-10-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (1.5 mg)
Inactive Ingredients
propylene glycol calcium pyrophosphate povidone k15 peg/ppg-116/66 copolymer polyethylene glycol 600 glycerin hydrogen peroxide sodium lauryl sulfate silicon dioxide sodium pyrophosphate saccharin sodium sodium acid pyrophosphate sucralose butylated hydroxytoluene

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug completed Since 2019-10-14 Until 2025-12-31

Purpose

Anticavity

Description

Drug Facts


Medication Information

Purpose

Anticavity

Directions
adults and children 6 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 6 to 12 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 6 years do not use unless directed by a dentist or physician
Inactive Ingredients

Propylene Glycol, Calcium Pyrophosphate, PVP, PEG/PPG-116/66 Copolymer, PEG-12, Glycerin, Flavor, Hydrogen Peroxide, Sodium Lauryl Sulfate, Silica, Tetrasodium Pyrophosphate, Sodium Saccharin, Disodium Pyrophosphate, Sucralose, BHT.

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 Monofluorophosphate 1.14% (0.19% w/v fluoride ion)

Principal Display Panel 127 G Tube Carton

Colgate®

Anticavity Fluoride Toothpaste

NOW 2X WHITENING INGREDIENT

OPTIC

WHITE®

ADVANCED

DEEPLY WHITENS FOR

UP TO FOUR SHADES*

HYDROGEN

2%

PEROXIDE

ENAMEL SAFE

NET WT 4.5 OZ (127 g)

VIBRANT CLEAN


Structured Label Content

Purpose

Anticavity

Directions
adults and children 6 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 6 to 12 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 6 years do not use unless directed by a dentist or physician
Inactive Ingredients (Inactive ingredients)

Propylene Glycol, Calcium Pyrophosphate, PVP, PEG/PPG-116/66 Copolymer, PEG-12, Glycerin, Flavor, Hydrogen Peroxide, Sodium Lauryl Sulfate, Silica, Tetrasodium Pyrophosphate, Sodium Saccharin, Disodium Pyrophosphate, Sucralose, BHT.

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 Monofluorophosphate 1.14% (0.19% w/v fluoride ion)

Principal Display Panel 127 G Tube Carton (PRINCIPAL DISPLAY PANEL - 127 g Tube Carton)

Colgate®

Anticavity Fluoride Toothpaste

NOW 2X WHITENING INGREDIENT

OPTIC

WHITE®

ADVANCED

DEEPLY WHITENS FOR

UP TO FOUR SHADES*

HYDROGEN

2%

PEROXIDE

ENAMEL SAFE

NET WT 4.5 OZ (127 g)

VIBRANT CLEAN


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)