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Antiseptic by CVS Pharmacy, Inc

Medically reviewed on February 17, 2017

Dosage form: mouthwash
Ingredients: EUCALYPTOL 0.92mg in 1mL, MENTHOL 0.42mg in 1mL, METHYL SALICYLATE 0.60mg in 1mL, THYMOL 0.64mg in 1mL
Labeler: CVS Pharmacy, Inc
NDC Code: 59779-072

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

Active ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.030%

Thymol 0.064%

purpose

antigingivituis, antiplaque

Use

   helps control plaque that leads to gingivitis

Warnings

   for this product

Do not use

if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth.  See your dentist immediately.  These may be signs of periodontitis, a serious form of gum disease.

Stop use and ask a dentist if

gingivitis, bleeding, or redness persists for more than 2 weeks

Keep out of reach of children

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • do not swallow
  • not inteneded to replace brushing or flossing

adults and children 12 years of age and older - vigorously swish 20 ml between teeth for 30 seconds then spit out

children under 12 years of age - consult a dentist or doctor

Other information

Store at room temperature (59° -77° F)

inactive ingredients

water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate, D&C yellow no. 10, FD&C green no.3

disclaimer

This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine FreshBurst Antiseptic

Adverse reactions

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

2016 CVS/pharmacy

CVS.com  V-16224

Principal Display Panel

CVS

Health

Compare to the active ingredients

in Listerine FreshBurst Antiseptic

Antiseptic Mouthwash

ANTIGINGIVITIS/ANTIPLAQUE

Kills germs that cause

plaque, gingivitis

& bad breath

Green Mint

ADA

Accepted

American

Dental

Association

  • Helps reduce plaque
  • Helps reduce gingivitis

Sealed with printed neckband for your protection.

Do not use if broken or missing

1.5 L (50.7 FL OZ)

ANTISEPTIC 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-072
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (EUCALYPTOL) EUCALYPTOL0.92 mg  in 1 mL
MENTHOL (MENTHOL) MENTHOL0.42 mg  in 1 mL
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE0.60 mg  in 1 mL
THYMOL (THYMOL) THYMOL0.64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
SORBITOL 
POLOXAMER 407 
BENZOIC ACID 
SACCHARIN SODIUM 
SODIUM CITRATE 
D&C YELLOW NO. 10 
FD&C GREEN NO. 3 
Packaging
#Item CodePackage Description
1NDC:59779-072-77500 mL in 1 BOTTLE, PLASTIC
2NDC:59779-072-861000 mL in 1 BOTTLE, PLASTIC
3NDC:59779-072-121500 mL in 1 BOTTLE, PLASTIC
4NDC:59779-072-69250 mL in 1 BOTTLE, PLASTIC
5NDC:59779-072-09887 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35608/09/1995
Labeler - CVS Pharmacy, Inc (062312574)
Registrant - Vi-Jon (790752542)

 
CVS Pharmacy, Inc

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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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