Colgate®

Colgate®
SPL v6
SPL
SPL Set ID 3dee7649-be7c-483c-a2b9-6939102ce5fb
Route
DENTAL
Published
Effective Date 2019-12-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1 mg)
Inactive Ingredients
Water Hydrated Silica Sorbitol Glycerin Polyethylene Glycol 600 Sodium Tripolyphosphate Anhydrous Sodium Pyrophosphate Sodium Lauryl Sulfate Carboxymethylcellulose Sodium, Unspecified Cocamidopropyl Betaine Benzyl Alcohol Saccharin Sodium Xanthan Gum Sodium Hydroxide Mica Titanium Dioxide Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-11-30 Until 2022-12-31

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

water, hydrated silica, sorbitol, glycerin, PEG-12, pentasodium triphosphate, tetrapotassium pyrophosphate, sodium lauryl sulfate, flavor, cellulose gum, cocamidopropyl betaine, benzyl alcohol, sodium saccharin, xanthan gum, sodium hydroxide, mica, titanium dioxide, FD&C blue no. 1

Principal Display Panel 119 G Tube Carton

NEW

STAIN REMOVAL

TECHNOLOGY**

Colgate®

OPTIC

WHITE®

STAIN FIGHTER ™

REMOVES 6X MORE SURFACE STAINS*

WITH MICRO-POLISHING ACTION

NET WT 4.2 OZ (119 g)

ANTICAVITY FLUORIDE TOOTHPASTE | ENAMEL SAFE WHITENING

FRESH MINT GEL


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)

water, hydrated silica, sorbitol, glycerin, PEG-12, pentasodium triphosphate, tetrapotassium pyrophosphate, sodium lauryl sulfate, flavor, cellulose gum, cocamidopropyl betaine, benzyl alcohol, sodium saccharin, xanthan gum, sodium hydroxide, mica, titanium dioxide, FD&C blue no. 1

Principal Display Panel 119 G Tube Carton (PRINCIPAL DISPLAY PANEL - 119 g Tube Carton)

NEW

STAIN REMOVAL

TECHNOLOGY**

Colgate®

OPTIC

WHITE®

STAIN FIGHTER ™

REMOVES 6X MORE SURFACE STAINS*

WITH MICRO-POLISHING ACTION

NET WT 4.2 OZ (119 g)

ANTICAVITY FLUORIDE TOOTHPASTE | ENAMEL SAFE WHITENING

FRESH MINT GEL


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)