Medication Guide App

Alcohol Free Antiseptic Oral

Dosage form: rinse
Ingredients: CETYLPYRIDINIUM CHLORIDE 0.07mL in 100L
Labeler: Topco Associates LLC
NDC Code: 36800-223

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.

Drug Facts

Sealed with printed neckband for your protection

TOP CARE
This TOP CARE product is laboratory tested to guarantee its highest quality.
Your total satisfaction is guaranteed.

Active ingredient
Cetylpyridinium chloride 0.07%

Purpose
Antigingivitis, Antiplaque

Use helps control plaque that leads to gingivitis

Warnings

Stop use and ask a dentist if •gingivitis, bleeding, or redness persists for more tan 2 weeks
•you have painful or swollen gums, pus from the gum 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,
get 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
•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 water, glycerin, propylene glycol, flavor, poloxamer 188, methylparaben, propylparaben, sodium saccharin, citric acid, yellow 6, green3

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

DISTRIBUTED BY TOPCO ASSOCIATES LLC
7711 GROSS POINT ROAD, SKOKIE, IL 60077
QUESTIONS? 1-888-423-0139
topcare@topco.com

ALCOHOL FREE
Antiseptic
ORAL
RINSE
ANTIGINGIVITIS/ANTIPLAQUE
•Kills germs that cause bad breath,
plaque and the gum disease gingivitis
Mint Flavor
COMPARE TO ACTIVE INGREDIENT OF CREST PRO-HEALTH RINSE
1 L (33.8 FL OZ)
ALCOHOL FREE ANTISEPTIC ORAL 
cetylpyridiium chloride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-223
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (CETYLPYRIDINIUM) CETYLPYRIDINIUM CHLORIDE0.07 mL  in 100 L
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
PROPYLENE GLYCOL 
POLOXAMER 188 
METHYLPARABEN 
PROPYLPARABEN 
SACCHARIN SODIUM DIHYDRATE 
CITRIC ACID MONOHYDRATE 
FD&C YELLOW NO. 6 
FD&C GREEN NO. 3 
Packaging
#Item CodePackage Description
1NDC:36800-223-861 L in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35602/15/1990
Labeler - Topco Associates LLC (006935977)
Registrant - Vi- Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon790752542manufacture

Revised: 04/2012
 
Topco Associates LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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