ALCOHOL FREE ANTISEPTIC- cetylpyridinium chloride rinse 
Demoulas Super Markets 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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Market Basket 223.001/223AC-AI  Drug Facts

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 with 20 mL (4teaspoonfuls) 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, propylene glycol, flavor, poloxamer 188, methylparaben, propylparaben, sodium saccharin, citric acid, yellow 6, green 3

For better oral hygiene and fresher breath

This product is not manufactured or distributed by Procter + Gamble, distributor of Crest Pro-Health Rinse

DISTRIBUTED BY
DEMOULAS SUPER MARKETS, INC
875 EAST STREET
TEWKSBURY, MA 01876

principal display panel

MORE FOR YOUR DOLLAR MARKET BASKET

Sealed with printed neckband for your protection

Compare to active ingredient in Crest Pro-Health Rinse

Multi-Action Alcohol-Free Antiseptic Oral Rinse with CPC

Antigingivitis/Antiplaque

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

Wintergreen flavor

1L (33.8 FL OZ)

image description

ALCOHOL FREE ANTISEPTIC 
cetylpyridinium chloride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53942-223
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.07 mg  in 100 L
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLOXAMER 188 (UNII: LQA7B6G8JG)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53942-223-861 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/16/201210/18/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35604/16/201210/18/2021
Labeler - Demoulas Super Markets Inc (007869647)
Registrant - Vi- Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(53942-223)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(53942-223)

Revised: 10/2021
Document Id: 81c0914f-7ba0-477d-b8dd-6e074b7f8e8c
Set id: 9668105b-acfc-4430-abbe-74b46f6c1583
Version: 11
Effective Time: 20211018
 
Demoulas Super Markets Inc