Colgate®

Colgate®
SPL v11
SPL
SPL Set ID 51296af5-4d95-4e9c-97c4-7defc13c9b7e
Route
DENTAL
Published
Effective Date 2023-01-27
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 Anhydrous Citric Acid Saccharin Sodium Sucralose Poloxamer 407 Fd&c Green No. 3

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2015-03-01 Until 2026-12-31

Description

Drug Facts

Purpose

Antigingivitis/Antiplaque


Medication Information

Purpose

Antigingivitis/Antiplaque

Description

Drug Facts

Uses
  • helps prevent and reduce plaque and gingivitis
  • helps control plaque bacteria that contribute to the development of gingivitis, an early form of gum disease, and bleeding gums
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.

Directions
adults and children 12 years of age and older vigorously swish 20 mL of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.
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

Stop Use and Ask A Dentist If
  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
Principal Display Panel 500 Ml Bottle Label

Colgate®

Antigingivitis Antiplaque Mouthwash

Total

GUM HEALTH

HELPS FIGHT PLAQUE AND GINGIVITIS

ANTIBACTERIAL

45% Stronger, Healthier Gums*

Fights Plaque Between Teeth & Along the Gum Line

Helps Prevent Gingivitis

10X LONGER LASTING COOL**

CLEAN MINT

16.9 FL OZ

(1.05 PT) 500 mL

P80040906


Structured Label Content

Uses
  • helps prevent and reduce plaque and gingivitis
  • helps control plaque bacteria that contribute to the development of gingivitis, an early form of gum disease, and bleeding gums
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.

Purpose

Antigingivitis/Antiplaque

Directions
adults and children 12 years of age and older vigorously swish 20 mL of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.
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 (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

Stop Use and Ask A Dentist If (Stop use and ask a dentist if)
  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
Principal Display Panel 500 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label)

Colgate®

Antigingivitis Antiplaque Mouthwash

Total

GUM HEALTH

HELPS FIGHT PLAQUE AND GINGIVITIS

ANTIBACTERIAL

45% Stronger, Healthier Gums*

Fights Plaque Between Teeth & Along the Gum Line

Helps Prevent Gingivitis

10X LONGER LASTING COOL**

CLEAN MINT

16.9 FL OZ

(1.05 PT) 500 mL

P80040906


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)