Colgate®

Colgate®
SPL v3
SPL
SPL Set ID f95496e3-11ec-4cd6-b3ee-cf6c657b790b
Route
DENTAL
Published
Effective Date 2019-10-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1 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 Active Since 2019-10-14

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 Monofluorophosphate 0.76% (0.12% w/v fluoride ion)

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.

Principal Display Panel 127 G Tube Carton

Colgate®

Anticavity

Fluoride Toothpaste

NOW

2X WHITENING INGREDIENT

OPTIC

WHITE®

ADVANCED

ENAMEL SAFE

NET WT 4.5 OZ (127 g)

DEEPLY WHITENS FOR

UP TO FOUR SHADES*

HYDROGEN

2%

PEROXIDE

ICY FRESH


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 Monofluorophosphate 0.76% (0.12% w/v fluoride ion)

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.

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

ENAMEL SAFE

NET WT 4.5 OZ (127 g)

DEEPLY WHITENS FOR

UP TO FOUR SHADES*

HYDROGEN

2%

PEROXIDE

ICY FRESH


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)