colgate®

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 blue no. 1

Identifiers & Packaging

Pill Appearance

Color: blue

Marketing Status

otc monograph drug completed Since 2024-10-31 Until 2027-08-31

Medication Information

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

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

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, Blue 1.

Description

Drug Facts

Questions?

1-800-468-6502

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.

Active Ingredient

Cetylpyridinium Chloride 0.075%

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

PEPPERMINT

24 HOUR ANTIBACTERIAL PROTECTION¹

Fight Root Cause² of:

✓Gingivitis ✓Plaque ✓Tartar Buildup

ADA

Accepted

American

Dental

Association ®

CLINICALLY

PROVEN

16.9 FL OZ (1.05 PT) 500 mL

PS0073264

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

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

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, Blue 1.

Questions?

1-800-468-6502

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.

Active Ingredient (Active ingredient)

Cetylpyridinium Chloride 0.075%

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

PEPPERMINT

24 HOUR ANTIBACTERIAL PROTECTION¹

Fight Root Cause² of:

✓Gingivitis ✓Plaque ✓Tartar Buildup

ADA

Accepted

American

Dental

Association ®

CLINICALLY

PROVEN

16.9 FL OZ (1.05 PT) 500 mL

PS0073264

Advanced Ingredient Data

[{"name": "CETYLPYRIDINIUM", "unii": "CUB7JI0JV3", "classCode": "ACTIB", "strengthNumerator": "15", "strengthDenominator": "20", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLOXAMER 407", "unii": "TUF2IVW3M2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ZINC LACTATE", "unii": "2GXR25858Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM SORBATE", "unii": "1VPU26JZZ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTIC ACID, UNSPECIFIED FORM", "unii": "33X04XA5AT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "42229-5": "Drug Facts", "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": "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, Blue 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": "ALCOHOL FREE Colgate ® Antigingivitis Antiplaque Mouthwash Total ACTIVE PREVENTION PEPPERMINT 24 HOUR ANTIBACTERIAL PROTECTION 1 Fight Root Cause 2 of: ✓Gingivitis ✓Plaque ✓Tartar Buildup ADA Accepted American Dental Association ® CLINICALLY PROVEN 16.9 FL OZ (1.05 PT) 500 mL PS0073264"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information