Colgate®

Colgate®
SPL v4
SPL
SPL Set ID 82ac5b9d-19e8-46ac-a195-c7d85f2967d5
Route
DENTAL
Published
Effective Date 2020-04-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.1 mg)
Inactive Ingredients
Water Hydrated Silica Sorbitol Glycerin Polyethylene Glycol 600 Sodium Tripolyphosphate Anhydrous Potassium Pyrophosphate Sodium Lauryl Sulfate Carboxymethylcellulose Sodium, Unspecified Cocamidopropyl Betaine Saccharin Sodium Xanthan Gum Sodium Hydroxide Activated Charcoal Fd&c Blue No. 1 Fd&c Red No. 40 Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Color: gray Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-05-05

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, Hydrated Silica, Sorbitol, Glycerin, PEG-12, Pentasodium Triphosphate, Tetrapotassium Pyrophosphate, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Cocamidopropyl Betaine, Sodium Saccharin, Xanthan Gum, Charcoal Powder, Sodium Hydroxide, Blue 1, Red 40, Titanium Dioxide.

Principal Display Panel 119 G Tube Carton

NEW

Colgate®

Anticavity Fluoride Toothpaste

OPTIC

WHITE®

WITH CHARCOAL

REMOVES 6X MORE SURFACE STAINS*

WITH MICRO-POLISHING ACTION

COOL MINT PASTE

ENAMEL SAFE

NET WT 4.2 OZ (119 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 Fluoride

0.24% (0.15% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

Water, Hydrated Silica, Sorbitol, Glycerin, PEG-12, Pentasodium Triphosphate, Tetrapotassium Pyrophosphate, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Cocamidopropyl Betaine, Sodium Saccharin, Xanthan Gum, Charcoal Powder, Sodium Hydroxide, Blue 1, Red 40, Titanium Dioxide.

Principal Display Panel 119 G Tube Carton (PRINCIPAL DISPLAY PANEL - 119 g Tube Carton)

NEW

Colgate®

Anticavity Fluoride Toothpaste

OPTIC

WHITE®

WITH CHARCOAL

REMOVES 6X MORE SURFACE STAINS*

WITH MICRO-POLISHING ACTION

COOL MINT PASTE

ENAMEL SAFE

NET WT 4.2 OZ (119 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)