ANTISEPTIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash 
Shopko Operating Co., 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

TEP

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 imediately. 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

Disclaimer

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

Adverse Reaction

Manufactured by Vi-Jon, Inc.,

One Swan Dr., Smyrna TN 37167

2012 ShopKo Stores Operating Co., LLC

www. shopko.com

For consumer questions

call 1-888-593 0593

principal display panel

Shopko

COMPARE TO THE ACTIVE INGREDIENTS OF LISTERINE

Antiseptic

Mouth

Rinse

Original

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

1.5 Liters (50.7 FL OZ)

image description

ANTISEPTIC 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-318
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:37012-318-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/09/1991
2NDC:37012-318-121500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/09/1991
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/09/1991
Labeler - Shopko Operating Co., LLC (023252638)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(37012-318)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(37012-318)

Revised: 6/2023
Document Id: 96c6230c-1e40-4ece-a057-a2a351450628
Set id: 6300ce58-01c0-483b-b5ac-6baa3a77d597
Version: 13
Effective Time: 20230608
 
Shopko Operating Co., LLC