Colgate®

Colgate®
SPL v3
SPL
SPL Set ID 7cb85fc4-573b-45d7-a430-f2fd17320c43
Route
DENTAL
Published
Effective Date 2024-05-30
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 Glycerin Cocamidopropyl Betaine Saccharin Sodium Powdered Cellulose Fd&c Blue No. 1 Titanium Dioxide Fd&c Yellow No. 5

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-28

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, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Tetrasodium Pyrophosphate, Cocamidopropyl Betaine, Sodium Saccharin, Hydroxypropyl Methylcellulose, Blue 1, Titanium Dioxide, Yellow 5.

Principal Display Panel 70.8 G Tube Carton

Colgate®

Anticavity

Fluoride Toothpaste

10x

LONGER

LASTING

COOL

MaxFresh®

WITH WHITENING

BREATH STRIPS

CLEAN MINT

NET WT 2.5 OZ (70.8 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, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Tetrasodium Pyrophosphate, Cocamidopropyl Betaine, Sodium Saccharin, Hydroxypropyl Methylcellulose, Blue 1, Titanium Dioxide, Yellow 5.

Principal Display Panel 70.8 G Tube Carton (PRINCIPAL DISPLAY PANEL - 70.8 g Tube Carton)

Colgate®

Anticavity

Fluoride Toothpaste

10x

LONGER

LASTING

COOL

MaxFresh®

WITH WHITENING

BREATH STRIPS

CLEAN MINT

NET WT 2.5 OZ (70.8 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)