colgate®

colgate®
SPL v2
SPL
SPL Set ID 54cbfb09-8fd7-ef08-99fd-14fc019c81ff
Route
dental
Published
Effective Date 2021-10-15
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 carboxymethylcellulose sodium lauryl sulfate saccharin sodium fd&c blue no. 1 d&c yellow no. 10

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
otc monograph drug active Since 2021-12-06

Purpose

Anticavity

Description

Drug Facts


Medication Information

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
Inactive Ingredients

Sorbitol, Water, Hydrated Silica, PEG-12, Cellulose Gum, Sodium Lauryl Sulfate, Flavor, Sodium Saccharin, Blue 1, Yellow 10.

Description

Drug Facts

Questions?

1-800-468-6502

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.

Active Ingredient

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Principal Display Panel 124 G Tube Label

Colgate®

Anticavity Fluoride Toothpaste

MAXIMUM

cavity

protection*

Bubble Fruit®

LESS

MESS

SPACE

JAM

A NEW LEGACY

ADA

Accepted

American

Dental

Association ®

NET WT 4.4 OZ (124 g)


Structured Label Content

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
Inactive Ingredients (Inactive ingredients)

Sorbitol, Water, Hydrated Silica, PEG-12, Cellulose Gum, Sodium Lauryl Sulfate, Flavor, Sodium Saccharin, Blue 1, Yellow 10.

Questions?

1-800-468-6502

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.

Active Ingredient (Active ingredient)

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Principal Display Panel 124 G Tube Label (PRINCIPAL DISPLAY PANEL - 124 g Tube Label)

Colgate®

Anticavity Fluoride Toothpaste

MAXIMUM

cavity

protection*

Bubble Fruit®

LESS

MESS

SPACE

JAM

A NEW LEGACY

ADA

Accepted

American

Dental

Association ®

NET WT 4.4 OZ (124 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)