COLGATE TOTAL ADVANCED GUM HEALTH MOUTHWASH- cetylpyridinium chloride rinse

Colgate Total Advanced Gum Health Mouthwash by

Drug Labeling and Warnings

Colgate Total Advanced Gum Health Mouthwash by is a Otc medication manufactured, distributed, or labeled by Colgate-Palmolive Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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

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

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

ALCOHOL FREE

Colgate®
Antigingivitis Antiplaque Mouthwash

Total™
WHOLE MOUTH HEALTH

GUM HEALTH
HELPS FIGHT PLAQUE & GINGIVITIS

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

P9930388

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
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

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	03/01/2015

Labeler - Colgate-Palmolive Company (001344381)