ANTISPETIC- cetylpyridinium chloride liquid 
Demoulas Super Markets

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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Drug Facts

claims

For better oral hygiene and fresher breath.

Active ingredient

Active ingredient

Cetylpyridinium chloride 0.07%

Purpose

Purpose

Antigingivitis, Antiplaque

Use

Use hlep control plaque that leads to gingivitis

Warnings

Warnings

Stop use

Stop use and ask a dentist if

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

Other information

Other information

Inactive ingredients

Inactive ingredients water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, methylparaben, sucralose, propylparaben, blue1

disclaimer

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

Adverse Reaction

DISTRIBUTED BY

DEMOULAS SUPER MARKETS, INC.

875 EAST STREET

TEWKSBURY, MA 01876

Principal Display Panel

More For Your Money

MARKET BASKET

Sealed with printed neckband for your protection

Compare to active ingredient in Crest PKILLS ro-Heal Rinse

Multi-Action

Alcohol-Free

ANTISEPTIC

ORAL RINSE

with CPC

Antigivitis/Antiplaque

Zesty Mint

1 L (33.8 FL OZ)

image description

ANTISPETIC 
cetylpyridinium chloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53942-299
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE 0.7 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:53942-299-86 1000 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 02/21/2012
Labeler - Demoulas Super Markets (007869647)
Registrant - Vi-Jon (790752542)
Establishment
Name Address ID/FEI Business Operations
Vi-Jon 790752542 manufacture(53942-299)

Revised: 12/2012
Document Id: 5229dd48-d2c7-4ec5-b8c2-9dd0369a6e09
Set id: 0162bc02-9c93-4f15-883c-68794c92e64d
Version: 1
Effective Time: 20121204
 
Demoulas Super Markets