ANTISEPTIC MOUTH RINSE- eucalyptol, menthol, methyl salicylate, thymol mouthwash 
Marc Glassman, 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.

----------

Antiseptic Mouthrinse
318.003/318AH-AI

Other Safety Inforamtion 

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

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 if

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

*This product is not manufactued or distributed by Johnson & Johnson Corporation, distributor of Original Listerine Antiseptic Mouthwash.

Distributed by:

Marc Glassman, Inc.

West 130th Street

Cleveland, OH 44130

Principal display panel

Marc's

*Compare to Original Listerine Mouthwash

Antseptic Mouthwash

Antigingivitis/Antiplaque

Kills Germs that Cause

Original Flavor

1.5 L (1.58 QY) 50.7 FL OZ

image description

ANTISEPTIC MOUTH RINSE 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68998-318
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:68998-318-121500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/15/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35604/15/2019
Labeler - Marc Glassman, Inc (094487477)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(68998-318)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(68998-318)

Revised: 4/2023
Document Id: bae06680-a2f2-4e68-b45c-d752e1a71b42
Set id: e668364b-907b-48fc-9fb2-97619607506b
Version: 6
Effective Time: 20230410
 
Marc Glassman, Inc