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 olderShake 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 ageunder adult supervision
chldren under 6 years of agedo 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

Principal Display Panel - 475 mL Bottle Label
COLGATE SIMPLY FRESH MINT 
cetylpyridinium chloride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-892
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE15 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35000-892-52475 mL in 1 BOTTLE; Type 0: Not a Combination Product01/13/202112/30/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35601/13/202112/30/2023
Labeler - Colgate-Palmolive (001344381)
Establishment
NameAddressID/FEIBusiness Operations
Colgate-Palmolive Company785047999ANALYSIS(35000-892) , LABEL(35000-892) , MANUFACTURE(35000-892) , PACK(35000-892)

Revised: 1/2021
Document Id: c3ee3449-53bc-4e47-b59a-de7bbfd38706
Set id: 2c7cf41d-cb68-5b28-72a9-84f1a2b48296
Version: 5
Effective Time: 20210113
 
Colgate-Palmolive