ANTISEPTIC- cetylpyridinium chloride mouthwash 
Onpoint, Inc

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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Antiseptic Mouthrinse
299

Active ingredient

Cetylpyridinium Chloride 0.07%

Purpose

Antigingivitis, Antiplaque

Use

helps control plaque that leads to gingivitis

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 increased 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 6 years & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
  • do not swallow
  • children 6 years to under 12 years of age: supervise use
  • when used after brushing, rinse mouth with water first
  • children under 6 years of age: do not use

Other information

  • this rinse is not intended to replace brushing or flossing

Inactive ingredients

water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, methylparaben, sucralose, propylparaben, blue 1

FOR BETTER ORAL HYGIENE AND FRESHER BREATH

KILLS MILLIONS OF GERMS WITHOUT THE BURN OF ALCOHOL

HELPS REMOVE GERMS THAT CAUSE PLAQUE, GINGIVITIS AND BAD BREATH

*This produc tis not manufatured or distributed by Procter + Gamble, distributor of Crest Pro-Health Rinse

DISTRIBUTED BY ONPOINT, INC

2 PARAGON DRIVE

MONTVALE, NJ 07645

Principal display panel

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTIN

LiveBetter

Alcohol-Free Antiseptic Oral Rinse

ZESTY MINT

Compare to Active Ingredients in Crest Pro-Health Rinse*

ANTIGINGIVITIS/ANTIPLAQUE MOUTHRINSE

  • KILLS GERMS
  • HELPS PREVENT PLAQUE
  • HELPS PREVENT GINGIVITIS
  • HELPS KEEP TEETH FEELING CLEAN
  • FRESHENS BREATH
  • NO BURN OF ALCOHOL

33.8 FL OZ (1 L)

image description

ANTISEPTIC 
cetylpyridinium chloride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51143-299
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.7 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLOXAMER 188 (UNII: LQA7B6G8JG)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
sucralose (UNII: 96K6UQ3ZD4)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51143-299-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/27/201006/10/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/27/201006/10/2021
Labeler - Onpoint, Inc (001367366)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(51143-299)

Revised: 6/2021
 
Onpoint, Inc