ANTISEPTIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash 
CVS Pharmacy, Inc

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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Drug Facts  CVS_072

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

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, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate, yellow no. 10, 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

Healh

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

Sealed with printed neckband for your protection. Do not use if broken or missing.

1.5 L (50.7 FL OZ)

image description

ANTISEPTIC 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-072
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL0.92 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.42 mg  in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.60 mg  in 1 mL
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL0.64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
SORBITOL (UNII: 506T60A25R)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-072-77500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/09/1995
2NDC:59779-072-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/09/1995
3NDC:59779-072-121500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/09/1995
4NDC:59779-072-69250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/09/1995
5NDC:59779-072-09887 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/09/1995
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, LLC (790752542)

Revised: 1/2022
Document Id: 247e7cbc-07c8-4c8e-aa47-b81cc6c87d9d
Set id: 06755465-7a74-40f8-9dd4-dbe24b8fec2a
Version: 11
Effective Time: 20220111
 
CVS Pharmacy, Inc