ANTISEPTIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash 
Valu Merchandisers Co

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; 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

Questions

Call 1-888-593-0593

Disclaimer

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

Adverse Reaction

Best Choice 100% Guarantee

Proudly Distributed By:

VALU MERCHANDISERS, CO

5000 KANSAS AVE

KANSAS CITY, MO 66106

principal display panel

Best

Choice

Sealed With Printed Neckband For Your Protection

COMPARE TO THE ACTIVE INGREDIENTS IN LISTERINE**

ANTISEPTIC

Mouth Rinse

ANTIGINGIVITIS/ANTIPLAQUE

ADA

Accepted

American Dental Association

Kills Germs That Cause Bad Breath, Plaque & Gingivitis Gum Disease

1 L (33.8 FL OZ)

image description

ANTISEPTIC 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-003
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:63941-003-77500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/09/1995
2NDC:63941-003-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/09/1995
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/09/1995
Labeler - Valu Merchandisers Co (868703513)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(63941-003)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(63941-003)

Revised: 6/2023
Document Id: f5e0e658-6757-43ff-81aa-2dc598c0ad5f
Set id: 93992f56-2e13-40d8-8e27-1f3989dd4c63
Version: 11
Effective Time: 20230606
 
Valu Merchandisers Co