Colgate®

Colgate®
SPL v1
SPL
SPL Set ID f83032bf-7ee8-4836-bd70-f7eaeab892cd
Route
DENTAL
Published
Effective Date 2025-10-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.1 mg)
Inactive Ingredients
Water Sorbitol Hydrated Silica Polyethylene Glycol 600 Sodium Lauryl Sulfate Carboxymethylcellulose Potassium Hydroxide Sodium Pyrophosphate Phosphoric Acid Cocamidopropyl Betaine Benzyl Alcohol Saccharin Sodium Fd&c Blue No. 1 Fd&c Red No. 3 Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Color: purple
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 Fluoride 0.24% (0.15% w/v fluoride ion)

Inactive Ingredients

Water, Sorbitol, Hydrated Silica, PEG-12, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Potassium Hydroxide, Tetrasodium Pyrophosphate, Phosphoric Acid, Cocamidopropyl Betaine, Benzyl Alcohol, Sodium Saccharin, Blue 1, Red 33, Titanium Dioxide.

Principal Display Panel 107 G Tube Carton

Colgate®

Anticavity Fluoride Toothpaste

OPTIC

WHITE®

PURPLE

PASTE FRESH MINT

REMOVES 1 YEAR

OF STAINS*

WITH MICRO-POLISHING ACTION

NET WT 3.8 OZ (107 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 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 Fluoride 0.24% (0.15% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

Water, Sorbitol, Hydrated Silica, PEG-12, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Potassium Hydroxide, Tetrasodium Pyrophosphate, Phosphoric Acid, Cocamidopropyl Betaine, Benzyl Alcohol, Sodium Saccharin, Blue 1, Red 33, Titanium Dioxide.

Principal Display Panel 107 G Tube Carton (PRINCIPAL DISPLAY PANEL - 107 g Tube Carton)

Colgate®

Anticavity Fluoride Toothpaste

OPTIC

WHITE®

PURPLE

PASTE FRESH MINT

REMOVES 1 YEAR

OF STAINS*

WITH MICRO-POLISHING ACTION

NET WT 3.8 OZ (107 g)

ENAMEL SAFE


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)