EMERALD MINT HEALTH- cetylpyridinium chloride mouthwash 
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
339

Active ingredient

Cetylpyridinium Chloride 0.07%

Purpose

Antigingivitis/Antiplaque

Use

helps control plaque that leads to gingivitis

Warnings

For this product

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 signs or symptoms of periodontitis, a serious form of gum sidease

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 12 years + older: vigorously swish 20 mL (4 teaspoonfuls) of rinse between your teeth twice a day for 30 seconds and then spit out
  • 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, alcohol (10.8wt%), glycerin, propylene glycol, flavor, poloxamer 407, sodium saccharin, yellow 6, green 3

Top Care Oral Health Antiseptic Mouth Rinse

*This product is not manufactured or distribued by Procter + Gamble, distributor of Crest Pro-health Invigorating Clean Multi-Protection Oral Rinse

This rinse may cause temporary staining to the surface of the teeth. This is not harmful, and adequate brushing may preven its occurance.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

1-888-423-0139

topcare@topco.com

DSP-TN-1500 DSP-MO-34 SDS-TN-15012

principal display panel

Sealed With Printed Neckband For Your Protection

EMERALD MINT

Oral Health

Antiseptic Mouth Rinse

Antigingivitis/Antiplaque

  • Promotes fresh breath while fighting gingivitis
  • Helps keep teeth feelig clean
  • Helps keep breath fresh

COMPARE TO CREST Pro-Health Invigorating Clean Multi-Protection Oral Rinse

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

image description

EMERALD MINT HEALTH 
cetylpyridinium chloride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-015
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.07 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-015-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/19/201311/09/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35609/19/201311/09/2021
Labeler - TopCo Associates LLC (006935977)
Registrant - Vi-Jon, LLC (790752549)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(36800-015)

Revised: 11/2021
 
TopCo Associates LLC