Colgate® Simply Fresh Mint

Colgate Simply Fresh Mint by

Drug Labeling and Warnings

Colgate Simply Fresh Mint by is a Otc medication manufactured, distributed, or labeled by Colgate-Palmolive. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COLGATE SIMPLY FRESH MINT- cetylpyridinium chloride mouthwash 
Colgate-Palmolive

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Colgate® Simply Fresh Mint

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 using and ask dentist if

• gingivitis, redness or bleeding persist for more than two 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: Shake vigorously before use. Vigorously swish 20 mL (⅔ of 1 fl. oz. or 4 teaspoons) 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: under adult supervision
• chldren under 6 years of age: do not use

Other information

• this rinse is not intended to replace brushing or flossing
• store between 59°F and 77°F
• keep from freezing

Inactive ingredients

Water, Glycerin, Propylene Glycol, Sorbitol, Poloxamer 407, Flavor, Potassium Sorbate, Citric Acid, Rebaudioside A.

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 475 mL Bottle Label

swish

SWISH AWAY
99%
OF GERMS

SIMPLY
FRESH MINT
MOUTHWASH

Colgate®

Antigingivitis/Antiplaque Mouthwash

16 FL OZ (1 PT) 475 mL

COLGATE SIMPLY FRESH MINT 
cetylpyridinium chloride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-892
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)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
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: 35000-892-52	475 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/13/2021	12/30/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	01/13/2021	12/30/2023

Labeler - Colgate-Palmolive (001344381)

Establishment
Name	Address	ID/FEI	Business Operations
Colgate-Palmolive Company		785047999	ANALYSIS(35000-892) , LABEL(35000-892) , MANUFACTURE(35000-892) , PACK(35000-892)

Revised: 1/2021

Document Id: c3ee3449-53bc-4e47-b59a-de7bbfd38706

34390-5

Set id: 2c7cf41d-cb68-5b28-72a9-84f1a2b48296

Version: 5

Effective Time: 20210113