RxNorm Names

Review RxNorm Normal Forms

ANTISEPTIC (cetylpyridinium chloride) mouthwash
[Wakefern Food Corp]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3bbd4a08-062f-40a3-a25b-f23490ee57f6

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

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

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

Antigingivitis, Antiplaque

Use

Use helps control plaque that leads to gingivitis

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

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

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41190-299
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (CETYLPYRIDINIUM)	CETYLPYRIDINIUM CHLORIDE	0.7 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water
GLYCERIN
POLOXAMER 188
SACCHARIN SODIUM DIHYDRATE
PROPYLENE GLYCOL
METHYLPARABEN
SUCRALOSE
PROPYLPARABEN
FD&C BLUE NO. 1

Packaging
#	Item Code	Package Description
1	NDC:41190-299-86	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	07/08/2011

Labeler - Wakefern Food Corp (069722418)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(41190-299)

Revised: 10/2012

Document Id: 4a69f6ff-b749-43bb-8579-b840087b528e

Set id: 3bbd4a08-062f-40a3-a25b-f23490ee57f6

Version: 2

Effective Time: 20121025

Wakefern Food Corp

Daily Med

Current Medication Information

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