colgate®

colgate®
SPL v4
SPL
SPL Set ID eba9c4f3-5199-4d9e-a9e2-04d3b5ab8f66
Route
dental
Published
Effective Date 2022-06-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (1 mg)
Inactive Ingredients
water sorbitol hydrated silica polyethylene glycol 600 sodium lauryl sulfate carboxymethylcellulose sodium, unspecified potassium pyrophosphate phosphoric acid cocamidopropyl betaine saccharin sodium benzyl alcohol activated charcoal fd&c blue no. 1 fd&c red no. 40 titanium dioxide

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug completed Since 2022-06-01 Until 2024-12-31

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, Charcoal Powder, Blue 1, Red 40, Titanium Dioxide.

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 119 G Tube Carton

Colgate®

Anticavity Fluoride Toothpaste

OPTIC

WHITE®

WITH CHARCOAL

REMOVES 5X MORE SURFACE STAINS*

WITH MICRO-POLISHING ACTION

COOL MINT PASTE

ENAMEL SAFE

NET WT 4.2 OZ (119 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, Charcoal Powder, Blue 1, Red 40, Titanium Dioxide.

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 119 G Tube Carton (PRINCIPAL DISPLAY PANEL - 119 g Tube Carton)

Colgate®

Anticavity Fluoride Toothpaste

OPTIC

WHITE®

WITH CHARCOAL

REMOVES 5X MORE SURFACE STAINS*

WITH MICRO-POLISHING ACTION

COOL MINT PASTE

ENAMEL SAFE

NET WT 4.2 OZ (119 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)