Colgate®

Colgate®
SPL v1
SPL
SPL Set ID ecebd253-e134-4c1e-b105-d53dcc7e0d79
Route
DENTAL
Published
Effective Date 2025-10-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.984 mg)
Inactive Ingredients
Propylene Glycol Calcium Pyrophosphate Peg/ppg-116/66 Copolymer Water Hydrogen Peroxide Povidone, Unspecified Silicon Dioxide Sodium Lauryl Sulfate Sodium Pyrophosphate Saccharin Sodium Sodium Acid Pyrophosphate Sucralose Butylated Hydroxytoluene

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-11

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, PEG/PPG-116/66 Copolymer, Water, Hydrogen Peroxide (5% w/v), PVP, Silica, Flavor, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Sodium Saccharin, Disodium Pyrophosphate, Sucralose, BHT.

Principal Display Panel 85 G Tube Carton

Colgate®

Anticavity Fluoride Toothpaste

OPTIC

WHITE®

PRO SERIES

REMOVES

15 YEARS

OF DEEP-SET STAINS*

ACTIVSHINE

TECHNOLOGY

5%

HYDROGEN

PEROXIDE

VIBRANT CLEAN

PASTE FRESH MINT

ENAMEL SAFE

NET WT 3.0 OZ (85 g)


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, PEG/PPG-116/66 Copolymer, Water, Hydrogen Peroxide (5% w/v), PVP, Silica, Flavor, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Sodium Saccharin, Disodium Pyrophosphate, Sucralose, BHT.

Principal Display Panel 85 G Tube Carton (PRINCIPAL DISPLAY PANEL - 85 g Tube Carton)

Colgate®

Anticavity Fluoride Toothpaste

OPTIC

WHITE®

PRO SERIES

REMOVES

15 YEARS

OF DEEP-SET STAINS*

ACTIVSHINE

TECHNOLOGY

5%

HYDROGEN

PEROXIDE

VIBRANT CLEAN

PASTE FRESH MINT

ENAMEL SAFE

NET WT 3.0 OZ (85 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)