ANTISEPTIC MOUTH RINSE- eucalyptol, menthol, methyl salicylate, thymol mouthwash 
Chain Drug Consortium

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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Antiseptic Mouthrinse
318.003/318AH-AI

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 children

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

Directions

Adult and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonsful) between teeth 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 not manufactured or directed by Johnson & Johnson Healthcare Poroducts, distributor of Original Listerine Antiseptic Mouthwash

Adverse Reactions

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund. 

DISTRIBUTED BY

Pharmacy Value Alliance LLC

407 East Lancaster Avenue,

Wayne, PA 19087

principal display panel

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

COMPARE TO ORIGINAL LISTERINE ANTISEPTIC MOUTHWASH*

Premier

Value

Antiseptic

Mouthrinse

Antigingivitis/Antiplaque

original

kills germs that cause

bad breath, plaque & the

gum disease gingivitis

1 L (33.8 FL OZ)

image description

ANTISEPTIC MOUTH RINSE 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-318
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:68016-318-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/19/2003
2NDC:68016-318-77500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/19/2003
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35608/19/2003
Labeler - Chain Drug Consortium (101668460)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(68016-318)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(68016-318)

Revised: 6/2023
Document Id: ecc92307-60d2-4862-bd12-06e9752de39f
Set id: d7c047b6-de1f-4e7e-8e4d-6fd80c8f8d2f
Version: 13
Effective Time: 20230607
 
Chain Drug Consortium