Colgate®

Colgate®
SPL v1
SPL
SPL Set ID fb63b8bb-826a-42e6-a429-b8d86c5c9223
Route
DENTAL
Published
Effective Date 2024-10-04
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 Zinc Lactate Potassium Sorbate Lactic Acid, Unspecified Form Saccharin Sodium Sucralose Fd&c Green No. 3

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-31

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
Inactive Ingredients

Water, Glycerin, Propylene Glycol, Sorbitol, Poloxamer 407, Zinc Lactate, Flavor, Potassium Sorbate, Lactic Acid, Sodium Saccharin, Sucralose, Green 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

ALCOHOL FREE

Colgate®

Antigingivitis Antiplaque Mouthwash

Total

ACTIVE PREVENTION

GUM HEALTH

Helps Prevent Gingivitis

24 HOUR ANTIBACTERIAL PROTECTION1

Fight Rood Cause2 of:

✓Gingivitis ✓Plaque ✓Tartar Buildup

ADA

Accepted

American

Dental

Association

CLINICALLY

PROVEN

16.9 FL OZ (1.05 PT) 500 mL

PS0073268


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
Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Propylene Glycol, Sorbitol, Poloxamer 407, Zinc Lactate, Flavor, Potassium Sorbate, Lactic Acid, Sodium Saccharin, Sucralose, Green 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)

ALCOHOL FREE

Colgate®

Antigingivitis Antiplaque Mouthwash

Total

ACTIVE PREVENTION

GUM HEALTH

Helps Prevent Gingivitis

24 HOUR ANTIBACTERIAL PROTECTION1

Fight Rood Cause2 of:

✓Gingivitis ✓Plaque ✓Tartar Buildup

ADA

Accepted

American

Dental

Association

CLINICALLY

PROVEN

16.9 FL OZ (1.05 PT) 500 mL

PS0073268


Advanced Ingredient Data


Raw Label Data

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