Colgate ®

Colgate ®
SPL v1
SPL
SPL Set ID 330d9e18-257d-2b50-e054-00144ff88e88
Route
DENTAL
Published
Effective Date 2014-12-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetylpyridinium (15 mg)
Inactive Ingredients
Water Glycerin Propylene Glycol Sorbitol Poloxamer 407 Potassium Sorbate Saccharin Sodium Levomenthol Anhydrous Citric Acid Sucralose Fd&c Green No. 3 Fd&c Yellow No. 6

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-05-06

Description

Drug Facts

Purpose

Antigingivitis/antiplaque


Medication Information

Purpose

Antigingivitis/antiplaque

Description

Drug Facts

Uses

helps prevent and reduce plaque and gingivitis

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Section 50569-3

Ask a dentist if condition persists or worsens after regular use.

Directions
adults and children 12 years of age and older rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day. Do not swallow.
children 6 years to under 12 years of age supervise use
children under 6 years of age do not use
Questions?

1-800-468-6502

Active Ingredient

Cetylpyridinium chloride 0.075%

Other Information
  • this rinse is not intended to replace brushing or flossing
  • store at 59°F to 77°F
  • keep from freezing
Inactive Ingredients

water, glycerin, propylene glycol, sorbitol, poloxamer 407, flavor, potassium sorbate, sodium saccharin, citric acid, sucralose, FD&C green no. 3, FD&C yellow no. 6

Principal Display Panel 500 Ml Bottle Label

ALCOHOL FREE

Colgate ®

Antigingivitis/Antiplaque Mouthwash

Total ®

ADVANCED

PRO-SHIELD

12-HR Protection Against Germs*

  • KILLS 99% OF GERMS ON CONTACT
  • SIGNIFICANTLY REDUCES PLAQUE
  • HELPS PREVENT GINGIVITIS
  • NO BURN OF ALCOHOL
  • FRESHENS BREATH

SPEARMINT SURGE™

16.9 FL OZ

(1.05 PT)

500 mL

P9892865


Structured Label Content

Uses

helps prevent and reduce plaque and gingivitis

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 rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Section 50569-3 (50569-3)

Ask a dentist if condition persists or worsens after regular use.

Purpose

Antigingivitis/antiplaque

Directions
adults and children 12 years of age and older rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day. Do not swallow.
children 6 years to under 12 years of age supervise use
children under 6 years of age do not use
Questions?

1-800-468-6502

Active Ingredient (Active ingredient)

Cetylpyridinium chloride 0.075%

Other Information
  • this rinse is not intended to replace brushing or flossing
  • store at 59°F to 77°F
  • keep from freezing
Inactive Ingredients (Inactive ingredients)

water, glycerin, propylene glycol, sorbitol, poloxamer 407, flavor, potassium sorbate, sodium saccharin, citric acid, sucralose, FD&C green no. 3, FD&C yellow no. 6

Principal Display Panel 500 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label)

ALCOHOL FREE

Colgate ®

Antigingivitis/Antiplaque Mouthwash

Total ®

ADVANCED

PRO-SHIELD

12-HR Protection Against Germs*

  • KILLS 99% OF GERMS ON CONTACT
  • SIGNIFICANTLY REDUCES PLAQUE
  • HELPS PREVENT GINGIVITIS
  • NO BURN OF ALCOHOL
  • FRESHENS BREATH

SPEARMINT SURGE™

16.9 FL OZ

(1.05 PT)

500 mL

P9892865


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)