Colgate®

Colgate®
SPL v10
SPL
SPL Set ID 3082e9ba-66d9-4fc7-bbe6-b41b60939bd2
Route
DENTAL
Published
Effective Date 2019-12-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: blue Color: white Color: green
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2010-12-01 Until 2026-12-31

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, sodium lauryl sulfate, flavor, PEG-12, tetrasodium pyrophosphate, cocamidopropyl betaine, cellulose gum, sodium saccharin, xanthan gum, titanium dioxide, FD&C blue no. 1, FD&C yellow no. 5

Principal Display Panel 232 G Tube Carton

Three Benefits for a Deep Clean

Colgate ®

Fluoride Toothpaste

NET WT 8.2 OZ (232 g)

Triple

Action

Original Mint

Cavity

Protection

1

Whiter

Teeth

2

Fresh

Breath

3


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, titanium dioxide, FD&C blue no. 1, FD&C yellow no. 5

Principal Display Panel 232 G Tube Carton (PRINCIPAL DISPLAY PANEL - 232 g Tube Carton)

Three Benefits for a Deep Clean

Colgate ®

Fluoride Toothpaste

NET WT 8.2 OZ (232 g)

Triple

Action

Original Mint

Cavity

Protection

1

Whiter

Teeth

2

Fresh

Breath

3


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)