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Emerald Mint Health

Dosage form: mouthwash
Ingredients: CETYLPYRIDINIUM CHLORIDE 0.07g in 1mL
Labeler: TopCo Associates LLC
NDC Code: 36800-015

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

Claims

Top Care

Oral Health

Antiseptic

Mouth Rinse

active ingredients

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

Other information

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

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

Disclaimer

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

Adverse reactions section

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

1-888-423-0139

topcare@topco.com

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)

EMERALD MINT HEALTH 
cetylpyridinium chloride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-015
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (CETYLPYRIDINIUM) CETYLPYRIDINIUM CHLORIDE0.07 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
GLYCERIN 
PROPYLENE GLYCOL 
POLOXAMER 407 
SACCHARIN SODIUM DIHYDRATE 
FD&C YELLOW NO. 6 
FD&C GREEN NO. 3 
Packaging
#Item CodePackage Description
1NDC:36800-015-861000 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35609/19/2013
Labeler - TopCo Associates LLC (006935977)
Registrant - Vi-Jon (790752549)
Establishment
NameAddressID/FEIOperations
Vi-Jon790752542manufacture(36800-015)

Revised: 02/2014
 
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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