ANTISEPTIC - cetylpyridinium chloride rinse 
DOLGENCORP, LLC

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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Oral Health
Mouth Rinse

For better oral hygiene
and fresher breath

SEALED WITH PRINTED
NECKBAND FOR YOUR PROTECTION

Active ingredient
Cetylpyridinium chloride 0.07%

Purpose
Antigingivitis, Antiplaque

Use helps control plaque that can lead 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 gun 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, tet 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
•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, citric acid, propylene glycol, methylparaben, propylparaben, blue 1

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

DISTRIBUTED BY
DOLGENCORP, LLC
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072
100%
Quality
Guaranteed
(888)309-9030

DG health
Oral Health
Mouth
Rinse
Zesty Mint Flavor
Compare to Active ingredient in
Crest Pro-Health Rinse
•Antigingivitis / Antiplaque
•Alcohol-Free
•Kills germs that cause bad breath
1 L ( 33.8 FL OZ)
image of principal display panel


ANTISEPTIC 
cetylpyridinium chloride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-299
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (CETYLPYRIDINIUM) CETYLPYRIDINIUM CHLORIDE0.07 kg  in 100 L
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
POLOXAMER 188 
SACCHARIN SODIUM DIHYDRATE 
CITRIC ACID MONOHYDRATE 
PROPYLENE GLYCOL 
METHYLPARABEN 
PROPYLPARABEN 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:55910-299-861 L in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/21/2008
Labeler - DOLGENCORP, LLC (068331990)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon790752542manufacture

Revised: 07/2012
 
DOLGENCORP, LLC