Your browser does not support JavaScript! ANTISEPTIC (CETYLPYRIDINIUM CHLORIDE) MOUTHWASH [WAKEFERN FOOD CORP]
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ANTISEPTIC (cetylpyridinium chloride) mouthwash
[Wakefern Food Corp]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Label Sections

Seal

Sealed with printed neckband for your protection

claims

For better oral hygiene and fresher 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

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 sings 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 Contol Center right away.

Directions

Directions

  • adults and children 6 years of age + older: rinse for 30 seconds with 20 mL (4 teaspoonsfuls) 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 product is not manufactured or distributed by Procter + Gamble, distributor of Crest Pro-Health Rinse

Adverse Reactions

DISTRIBUTED BY

WAKEFERN FOOD CORP

5000 RIVERSIDE DRIVE

KEASBEY, NJ 08832

1-800-SHOPRITE

www.shoprite.com

Principal display panel

Compare to active ingredient in Crest Pro-Health Rinse

ShopRite

Antiseptic

Oral Rinse

CPC Antigingivitis/Antiplaque

ALCOHOL FREE

  • Kills germs
  • Help prevent plaque
  • Helps keep teeth feeling clean
  • Freshen Breath
  • No Burn of alcohol

ZESTY MINT

1L (33.8 FL OZ)

image description

ANTISEPTIC 
cetylpyridinium chloride mouthwash
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41190-299
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 DescriptionMarketing Start DateMarketing End Date
1NDC:41190-299-861000 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/08/2011
Labeler - Wakefern Food Corp (069722418)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon790752542manufacture(41190-299)

Revised: 10/2012
 
Wakefern Food Corp

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