ANTISEPTIC MOUTH RINSE- eucalyptol, menthol, methyl salicylate, thymol mouthwash 
Demoulas Super Markets

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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Spring Mint Antiseptic Mouthrinse
072.003/072AL rev 2-AN

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 you 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.  It antiseptic properties are not affected.  Store at room temperature (59⁰ - 77⁰ F)

Inactive ingredients

water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate, D&C yellow no. 10, FD&C green no. 3

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributer or Listerine.

DISTRIBUTED BY:

DEMOULAS SUPER MARKETS, INC.

875 EAST STREET, TEWKSBURY, MA 01876

principal display panel

"MORE FOR YOUR DOLLAR"

MARKET BASKET

COMARE TO LISTERINE*

ANTISEPTIC

MOUTH RINSE

Fresh Mint

Kills germs that cause BAd Breath, Plaque and the gum disease Gingivitis

ADA Accepted 

American Dental Association

Sealed With Printed Neckband For Your Protection

500 mL (16.9 FL OZ)

image description

ANTISEPTIC MOUTH RINSE 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53942-072
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 SOLUTION (UNII: 8KW3E207O2)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53942-072-77500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2007
2NDC:53942-072-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2007
3NDC:53942-072-131250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2007
4NDC:53942-072-121500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2007
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/30/2007
Labeler - Demoulas Super Markets (007869647)
Registrant - Vi Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon, LLC790752542manufacture(53942-072)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon, LLC088520668manufacture(53942-072)

Revised: 1/2023
Document Id: e8a77b74-238d-4cce-ad4a-f38c6788f778
Set id: 87263c47-0977-487f-a348-8b9e2ee69446
Version: 14
Effective Time: 20230130
 
Demoulas Super Markets