COLGATE ZERO FRESH BREATH- cetylpyridinium chloride mouthwash

Colgate Zero Fresh Breath by

Drug Labeling and Warnings

Colgate Zero Fresh Breath by is a Otc medication manufactured, distributed, or labeled by Colgate-Palmolive Company, Colgate-Palmolive. 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, Zinc Lactate, Flavor, Potassium Sorbate, Lactic Acid, Rebaudioside A.

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 515 mL Bottle Label

Colgate®

zero

KILLS 99% OF GERMS

0% alcohol

0% dyes

0% artificial flavors

Fresh Breath

natural cool
peppermint

Antigingivitis/Antiplaque Mouthwash

17.4 FL OZ (1.08 PT) 515 mL

P9937239

INGREDIENTS AND APPEARANCE

COLGATE ZERO FRESH BREATH 
cetylpyridinium chloride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-882
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	15 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
ZINC LACTATE (UNII: 2GXR25858Y)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
REBAUDIOSIDE A (UNII: B3FUD0528F)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35000-882-56	515 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/12/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	12/12/2019

Labeler - Colgate-Palmolive Company (001344381)

Establishment
Name	Address	ID/FEI	Business Operations
Colgate-Palmolive		785047999	MANUFACTURE(35000-882)