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Antiseptic by Onpoint, Inc

Dosage form: mouthwash
Ingredients: CETYLPYRIDINIUM CHLORIDE 0.7mg in 1mL
Labeler: Onpoint, Inc
NDC Code: 51143-299

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.

Drug Facts

Optional Claims

FOR BETTER ORAL HYGIENE AND FRESHER BREATH

KILLS MILLIONS OF GERMS WITHOUT THE BURN OF ALCOOL

HELPS REMOVE GERMS THAT CAUSE PLAQUE, GINGIVITIS AND BAD BREATH

Active ingredient

Active ingredient
Cetylpyridinium Chloride 0.07%

Purpose

Purpose

Antigingivitis, Antiplaque

Use

Use helps control plaque that leads to gingivitis

Warnings

Warnings

Stop use and ask a dentist if

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

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

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

Other information

  • this rinse is not intended to replace brushing or flossing

Inactive ingredients

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

Disclaimer

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

Adverse Reaction

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)

ANTISEPTIC 
cetylpyridinium chloride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51143-299
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (CETYLPYRIDINIUM) CETYLPYRIDINIUM CHLORIDE0.7 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
POLOXAMER 188 
SACCHARIN SODIUM DIHYDRATE 
PROPYLENE GLYCOL 
METHYLPARABEN 
sucralose 
PROPYLPARABEN 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:51143-299-861000 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/27/2010
Labeler - Onpoint, Inc (001367366)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon790752542manufacture(51143-299)

 
Onpoint, Inc

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Medically reviewed on Oct 29, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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