ANTISEPTIC- 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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TopCare Antiseptic mouthrinse
299.005/295AK/AL

Active ingredient

Cetylpyridinium chloride 0.07%

Purpose

Antigingivitis, Antiplaque

USE

helps control plaque that leads to gingivitis

Warnings

for this product only

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 gun 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

other information

Inactive ingredients

water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid, blue 1

Questions?

Call 1-888-423-0139

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

TopCare everyday

This rinse may cause temporary staining to the surface of teeth.

This is not harmful, and adequate brushing may prevent its occurence

*This product is not manufactured or distributed by Procter & Gamble distributor of Crest Pro-Health Multi-Protection Alcohol Free Rinse-Refreshing Clean Mint

DISTRIBUTED BY TOPCO ASSOCIATES, LLC

ELK GROOVE VILLAGE, IL 60077

QUESTIONS? 1-888-423-0139

topcare@topcare.com  www.topcarebrand.com

This Top Care product is laboratory tested to guarantee its hightest quality.  Your total satisfaction is guaranteed.

principal display panel

COMPARE TO CREST PRO-HEALTH MOUTH RINSE

TopCare everyday

ALCOHOL FREE ORAL HEALTH Mouthwash

ANTIGINGIVITIS / ANTIPLAQUE

MINT

33.8 FL OZ (1 qt 1.8 FL OZ) 1L

image description

ANTISEPTIC 
cetylpyridinium chloride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-299
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.7 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLOXAMER 188 (UNII: LQA7B6G8JG)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-299-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/1993
2NDC:36800-299-2189 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/1993
3NDC:36800-299-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/03/1993
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35608/03/1993
Labeler - Topco Associates LLC (006935977)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(36800-299)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(36800-299)

Revised: 8/2022
Document Id: e6ad046c-c421-4eaf-a511-26b165ff0660
Set id: 857e8bc4-125f-4796-ac10-6880702816fe
Version: 11
Effective Time: 20220805
 
Topco Associates LLC