Colgate®

Colgate®
SPL v19
SPL
SPL Set ID 890c4c29-bba8-4775-a053-10c6292df930
Route
DENTAL
Published
Effective Date 2021-11-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.1 mg)
Inactive Ingredients
Sorbitol Water Hydrated Silica Polyethylene Glycol 600 Sodium Lauryl Sulfate Carboxymethylcellulose Sodium, Unspecified Saccharin Sodium Sodium Pyrophosphate Cocamidopropyl Betaine Hypromellose, Unspecified Fd&c Blue No. 1 Activated Charcoal Fd&c Red No. 40 Titanium Dioxide Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-10-01 Until 2023-12-31

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

Sorbitol, Water, Hydrated Silica, PEG-12, Flavor, Sodium Lauryl Sulfate, Cellulose Gum, Sodium Saccharin, Tetrasodium Pyrophosphate, Cocamidopropyl Betaine, Hydroxypropyl Methylcellulose, Blue 1, Charcoal Powder, Red 40, Titanium Dioxide, Yellow 5.

Principal Display Panel Two 170 G Tube Carton

Colgate®

Anticavity Fluoride Toothpaste

Recyclable

Tube

CHARCOAL MINT

2

VALUE

PACK

10X

LONGER

LASTING

COOL

MaxFresh®

WITH WHITENING

+ CHARCOAL

CHARCOAL MINT

TWO 6.0 OZ (170 g) TUBES • TOTAL NET WT 12 OZ (340 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)

Sorbitol, Water, Hydrated Silica, PEG-12, Flavor, Sodium Lauryl Sulfate, Cellulose Gum, Sodium Saccharin, Tetrasodium Pyrophosphate, Cocamidopropyl Betaine, Hydroxypropyl Methylcellulose, Blue 1, Charcoal Powder, Red 40, Titanium Dioxide, Yellow 5.

Principal Display Panel Two 170 G Tube Carton (PRINCIPAL DISPLAY PANEL - Two 170 g Tube Carton)

Colgate®

Anticavity Fluoride Toothpaste

Recyclable

Tube

CHARCOAL MINT

2

VALUE

PACK

10X

LONGER

LASTING

COOL

MaxFresh®

WITH WHITENING

+ CHARCOAL

CHARCOAL MINT

TWO 6.0 OZ (170 g) TUBES • TOTAL NET WT 12 OZ (340 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)