Colgate®

Colgate®
SPL v1
SPL
SPL Set ID a48e83ae-a02a-4a6d-a601-7acaba3bbbc9
Route
DENTAL
Published
Effective Date 2025-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (11.4 mg)
Inactive Ingredients
Propylene Glycol Calcium Pyrophosphate Peg/ppg-116/66 Copolymer Water Hydrogen Peroxide Povidone K30 Hydrated Silica 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 2025-11-24

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 Contol Center right away.

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
Questions?

1-800-468-6502

Active Ingredient

Sodium Monofluorophosphate 1.14% (0.18% w/v fluoride ion)

Inactive Ingredients

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

Principal Display Panel 85 G Tube Carton

Colgate®

Anticavity Fluoride Toothpaste

2

VALUE

PACK

OPTIC

WHITE®

PRO SERIES

REMOVES

15 YEARS

OF DEEP-SET STAINS*

ACTIVSHINE

TECHNOLOGY

5%

HYDROGEN

PEROXIDE

ENAMEL RENEWAL

PASTE

SOOTHING MINT

TWO 3.0 OZ (85 g) TUBES • TOTAL NET WT 6.0 OZ (170 g)

ENAMEL SAFE


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 Contol Center right away.

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
Questions?

1-800-468-6502

Active Ingredient (Active ingredient)

Sodium Monofluorophosphate 1.14% (0.18% 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, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Flavor, Sodium Saccharin, Disodium Pyrophosphate, Sucralose, BHT.

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

Colgate®

Anticavity Fluoride Toothpaste

2

VALUE

PACK

OPTIC

WHITE®

PRO SERIES

REMOVES

15 YEARS

OF DEEP-SET STAINS*

ACTIVSHINE

TECHNOLOGY

5%

HYDROGEN

PEROXIDE

ENAMEL RENEWAL

PASTE

SOOTHING MINT

TWO 3.0 OZ (85 g) TUBES • TOTAL NET WT 6.0 OZ (170 g)

ENAMEL SAFE


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)