HEALTH- cetylpyridinium chloride mouthwash 
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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Drug facts

Claims

Oral Health

Mouth

Rinse

For better oral hygiene

and fresher breath

safety seal

Sealed with printed neckband for your protection

Active ingredients

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

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, blue 1

Disclaimer

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

Adverse Reactions

DISTRIBUTED BY

DOLGENCORP, LLC

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Principal display panel

DGhealth

Oral Health

MOUTH
RINSE

Zesty Mint Flavor

Compare to active ingredient in Crest Pro-Health Rinse

1 L (33.8 FL OZ)

image description

HEALTH 
cetylpyridinium chloride mouthwash
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55910-299
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 
PROPYLENE GLYCOL 
METHYLPARABEN 
SUCRALOSE 
PROPYLPARABEN 
Other Ingredients
Ingredient KindIngredient NameQuantity
Does not containFD&C BLUE NO. 10 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-299-861000 mL 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(55910-299)

Revised: 2/2013
Document Id: 25b2ad45-150b-47b5-bfc6-753cebb83a11
Set id: d870e73a-2f35-4fa1-861c-81bd63603d3b
Version: 3
Effective Time: 20130226
 
DOLGENCORP, LLC