Colgate®

Colgate®
SPL v2
SPL
SPL Set ID 95d06fcc-f56d-43f1-924a-3f91fda59bdf
Route
DENTAL
Published
Effective Date 2020-08-11
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 Sodium Lauryl Sulfate Polyethylene Glycol 600 Sodium Pyrophosphate Cocamidopropyl Betaine Carboxymethylcellulose Sodium, Unspecified Saccharin Sodium Xanthan Gum Activated Charcoal Fd&c Blue No. 1 Fd&c Red No. 40

Identifiers & Packaging

Pill Appearance
Color: gray
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-07-31

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, Sodium Lauryl Sulfate, Flavor, PEG-12, Tetrasodium Pyrophosphate, Cocamidopropyl Betaine, Cellulose Gum, Sodium Saccharin, Xanthan Gum, Charcoal Powder, Blue 1, Red 40.

Principal Display Panel 62 G Tube Carton

Colgate®

Anticavity Fluoride Toothpaste

ULTRA

WHITE

- with Charcoal -

Formula helps lift surface stains to whiten teeth

paste

NET WT 2.2 OZ (62 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, Sodium Lauryl Sulfate, Flavor, PEG-12, Tetrasodium Pyrophosphate, Cocamidopropyl Betaine, Cellulose Gum, Sodium Saccharin, Xanthan Gum, Charcoal Powder, Blue 1, Red 40.

Principal Display Panel 62 G Tube Carton (PRINCIPAL DISPLAY PANEL - 62 g Tube Carton)

Colgate®

Anticavity Fluoride Toothpaste

ULTRA

WHITE

- with Charcoal -

Formula helps lift surface stains to whiten teeth

paste

NET WT 2.2 OZ (62 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)