Drug Facts

Active ingredient

Cetylpyridinium chloride 0.075%

Purpose

Antigingivitis/Antiplaque

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

Warnings

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.

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

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

Questions?

1-800-468-6502

Dist. by:
COLGATE-PALMOLIVE CO.
New York, NY 10022 U.S.A.

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

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

COLGATE TOTAL ADVANCED GUM HEALTH MOUTHWASH
cetylpyridinium chloride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:35000-723
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.75 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)
POLOXAMER 407 (UNII: TUF2IVW3M2)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

Product Characteristics
Color	GREEN	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:35000-723-16	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2015	12/31/2026
2	NDC:35000-723-33	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2015	12/31/2026
3	NDC:35000-723-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2015	12/30/2023
4	NDC:35000-723-84	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2015	12/30/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH DRUG	505G(a)(3)	03/01/2015	12/31/2026

Labeler - Colgate-Palmolive Company (001344381)

Name	Address	ID/FEI	Business Operations
Establishment
Colgate-Palmolive Company		785047999	ANALYSIS(35000-723) , LABEL(35000-723) , MANUFACTURE(35000-723) , PACK(35000-723)

Colgate® Total® Advanced Gum Health Mouthwash