ORIGINAL ANTISEPTIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash 
Topco Associates, LLC

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

adults and children 12 years of age and older vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) 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 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

Disclaimer

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Original Listerine Antispetic Mouthwash

TEP

SEALED WTH PRINTED NECKBAND FOR YOUR PROTECTION

Adverse Reactions

DISTRIBUTED BY: TOPCO ASSOCIATES LLC

SKOKIE, IL 60077

QUESTIONS? 1-888-423-0139   

topcare@copco.com      www.topcobrand.com

Quality Guaranteed

Principal display panel

COMPARE TO LISTERINE*

TopCare

everyday

Antiseptic

Mouthwash

ANTIGINGIVITIS/ANTIPLAQUE

ORIGINAL FLAVOR

ADA Accepted

American Dental Association

8.5 FL OZ (250 mL)

image description

ORIGINAL ANTISEPTIC 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-318
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:36800-318-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/1990
2NDC:36800-318-69250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/1990
3NDC:36800-318-121500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/1990
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/15/1990
Labeler - Topco Associates, LLC (006935977)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(36800-318)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(36800-318)

Revised: 6/2023
Document Id: b9d0c3f7-0562-4380-b38a-f2a3210edadb
Set id: b6c8d5b1-4b19-463c-826a-cccdcec09e2d
Version: 10
Effective Time: 20230609
 
Topco Associates, LLC