ANTISEPTIC MOUTH RINSE- 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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CVS 318.003 - 318AI

Active ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Purpose

Antigingivitis, 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

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

Keep out of reach of chrildren

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 (2/3 FL OZ or 4 teaspoonfuls) between teeth twice a day for 30 seconds then spit out; do not swallow

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

Other information

cold weather may cloud this product.  Its antiseptic properties are not affected.  Store at room temperature (59°-77°F).

Inactive ingredients

water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

Disclaimer

This product is manufactued or distributed by Johnson & Johnson Healthcare Products, distributor of  Original Listerine Antiseptic Mouthwash

Adverse reactions

Distributed by:  CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

318.003/318AH

2019 CVS/pharmacy

CVS.com 1-800-SHOPCVS

Made in the U.S.A. of U.S. and oreign components

V-16224

CVS Quality

Money Back Guarantee

DSP-TN-15000

DSP--MO-34

SDS-TN-15012

principal display panel

Compare to the active ingredients in Listerine Original Antiseptic

CVS

Health

Antiseptic

Mouthwash

ANTIGINGIVITIS/ANTPLAQUE

Kills gemrs that cause plaque, gingivitis & bad breath

Original

ADA

Accepted

American

Dental

Association

Sealed with printed neckband for your protection.

Do not use if broken or missing

1L (33.8 FL OZ)

image description

ANTISEPTIC MOUTH RINSE 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-898
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)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CARAMEL (UNII: T9D99G2B1R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-898-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/12/2009
2NDC:59779-898-69250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/12/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/12/2009
Labeler - CVS Pharmacy, Inc (062312574)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(59779-898)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(59779-898)

Revised: 9/2023
Document Id: ebdda38f-6549-4a29-9a57-e170fd6d28c5
Set id: 204025ac-af00-48a0-be8e-7ccc7a36ad45
Version: 21
Effective Time: 20230927
 
CVS Pharmacy, Inc