ANTISPETIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash 
Big Lots

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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Sound Body 664.003 -664AU

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

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

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

Inactive ingredients

water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, FD&C green no.3

Questions or comments

1-888-593-0593

Disclaimer

This product is not manufactured or distributed by Johnson & Johnson Healthcare products, distributor of Cool Mint Listerine Antiseptic Mouthwash

Adverse Reactions

Manufactured By; Vi-Jon, Inc.

for Big Lots

8515 Page Ave

St. Louis, MO 63114

V#425040

ITEM 664

principal display panel

SOUND BODY

Compare to active

Ingredients in Cool Mint

Listerine Antseptic

ANTISEPTIC

Mouthrinse

Antigingivitis/Antiplaque

Kills Germs That Cause:

BLUE MINT

1.5 L (1 QT 1 PT 2.7 FL OZ) 50.7 FL OZ

image description

ANTISPETIC 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50594-664
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)  
SORBITOL (UNII: 506T60A25R)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50594-664-121500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/30/2015
2NDC:50594-664-77500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/30/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35604/30/2015
Labeler - Big Lots (017885351)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(50594-664)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(50594-664)

Revised: 5/2022
Document Id: d5f9cf02-2c35-467b-9a0f-a73c36ca87a6
Set id: 9256d3b2-50eb-4091-bbcd-1982865fb998
Version: 13
Effective Time: 20220523
 
Big Lots