ALCOHOL FREE ANTISEPTIC ORAL- cetylpyridinium chloride rinse 
Topco Associates 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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Top Care 
223.001/223AC-AI

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

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.

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

principal display panel

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)

image description

ALCOHOL FREE ANTISEPTIC ORAL 
cetylpyridinium chloride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-223
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.07 mg  in 100 L
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLOXAMER 188 (UNII: LQA7B6G8JG)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-223-861 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/15/199011/09/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35602/15/199011/09/2021
Labeler - Topco Associates LLC (006935977)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(36800-223)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(36800-223)

Revised: 11/2021
Document Id: 8041ccc3-a757-4fe7-9b47-1f1dc64c778c
Set id: c1b1ca8f-28bc-42ac-8bd5-4cca87b912cb
Version: 11
Effective Time: 20211109
 
Topco Associates LLC