Colgate®

Colgate®
SPL v14
SPL
SPL Set ID cb15af39-c146-4aab-9771-d42832a2c4b2
Route
DENTAL
Published
Effective Date 2023-01-12
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 Anhydrous Citric Acid Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2013-05-06 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, FD&C blue no. 1

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

12 HR PROTECTION*

EVEN AFTER EATING AND DRINKING

ANTIBACTERIAL

Kills 99% of Germs on Contact

Significantly Reduces Plaque

Helps Prevent Gingivitis

10X LONGER LASTING COOL**

PEPPERMINT

16.9 FL OZ

(1.05 PT) 500 mL

PS0040932


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, FD&C blue no. 1

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

12 HR PROTECTION*

EVEN AFTER EATING AND DRINKING

ANTIBACTERIAL

Kills 99% of Germs on Contact

Significantly Reduces Plaque

Helps Prevent Gingivitis

10X LONGER LASTING COOL**

PEPPERMINT

16.9 FL OZ

(1.05 PT) 500 mL

PS0040932


Advanced Ingredient Data


Raw Label Data

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