colgate®

colgate®
SPL v6
SPL
SPL Set ID 8e6113e2-101b-4bde-90e9-6ab32c6ebf5c
Route
dental
Published
Effective Date 2024-06-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (1.1 mg)
Inactive Ingredients
water hydrated silica sorbitol glycerin polyethylene glycol 600 sodium tripolyphosphate anhydrous potassium pyrophosphate sodium lauryl sulfate cocamidopropyl betaine saccharin sodium xanthan gum sodium hydroxide sodium bicarbonate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2023-01-01

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

Water, Sorbitol, Hydrated Silica, PEG-12, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Potassium Hydroxide, Tetrasodium Pyrophosphate, Phosphoric Acid, Cocamidopropyl Betaine, Sodium Saccharin, Benzyl Alcohol, Sodium Bicarbonate.

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 85 G Tube Carton

Colgate®

Anticavity Fluoride Toothpaste

Clean Mint Paste

ENAMEL SAFE

Removes 95% of

Daily Surface Stains*

with Micro-Polishing Action

OPTIC

WHITE®

STAIN FIGHTER®

with Baking Soda

NET WT

3.0 OZ (85 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)

Water, Sorbitol, Hydrated Silica, PEG-12, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Potassium Hydroxide, Tetrasodium Pyrophosphate, Phosphoric Acid, Cocamidopropyl Betaine, Sodium Saccharin, Benzyl Alcohol, Sodium Bicarbonate.

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 85 G Tube Carton (PRINCIPAL DISPLAY PANEL - 85 g Tube Carton)

Colgate®

Anticavity Fluoride Toothpaste

Clean Mint Paste

ENAMEL SAFE

Removes 95% of

Daily Surface Stains*

with Micro-Polishing Action

OPTIC

WHITE®

STAIN FIGHTER®

with Baking Soda

NET WT

3.0 OZ (85 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)