Colgate ®

Colgate ®
SPL v1
SPL
SPL Set ID 330dda24-9b4b-2dca-e054-00144ff8d46c
Route
DENTAL
Published
Effective Date 2015-11-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetylpyridinium (0.75 mg)
Inactive Ingredients
Water Glycerin Propylene Glycol Sorbitol Potassium Sorbate Citric Acid Monohydrate Saccharin Sodium Sucralose Poloxamer 407 Fd&c Green No. 3

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-03-01

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, citric acid, sodium saccharin, sucralose, FD&C green no. 3

Principal Display Panel 500 Ml Bottle Label

ALCOHOL FREE

Colgate ®

Antigingivitis Antiplaque Mouthwash

Total ®

GUM HEALTH

Advanced Gum Protection for

45% Stronger, Healthier Gums*

  • Fights plaque between teeth & along

    the gum line
  • Kills 99% of germs on contact
  • 12-hour protection against bacteria

    that cause gingivitis

CLEAN MINT

16.9 FL OZ

(1.05 PT)

500 mL

P9903746


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, citric acid, sodium saccharin, sucralose, FD&C green no. 3

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

ALCOHOL FREE

Colgate ®

Antigingivitis Antiplaque Mouthwash

Total ®

GUM HEALTH

Advanced Gum Protection for

45% Stronger, Healthier Gums*

  • Fights plaque between teeth & along

    the gum line
  • Kills 99% of germs on contact
  • 12-hour protection against bacteria

    that cause gingivitis

CLEAN MINT

16.9 FL OZ

(1.05 PT)

500 mL

P9903746


Advanced Ingredient Data


Raw Label Data

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