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

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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Active ingredients
Eucalyptol 0.092%, Menthol 0.042%
Methyl salicylate 0.060%, Thymol 0.064%

Purpose
Antiginvitis, Antiplaque

Use helps control plaque that leads to gingivitis

Warnings

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 • this rinse is not intended to replace brushing or flossing

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 (59⁰-77⁰F)

Inactive ingredients water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

This product is not manufactured or distributed by Johnson + Johnson Healthcare products, distributor of Listerine

DSP-TN-15000
DSP-MO-34
SDS-TN-15012

Distributed By:
Demoulas Super Markets, Inc.
875 East Street
Tewsbury, MA 01876

Market
Basket
Compare to Listerine
ANTISEPTIC
MOUTH RINSE
Orginal
Kills germs that
cause Bad breath,
Plaque and the gum
disease Gingivitis
Sealed With Printed Neckband For Your Protection
1 L (33.8 FL OZ)
image of principal display panel

ANTISEPTIC MOUTH RINSE 
eucalyptol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53942-318
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (EUCALYPTOL) EUCALYPTOL.092 kg  in 100 L
MENTHOL (MENTHOL) MENTHOL.042 kg  in 100 L
METHYL SALICYLATE (METHYL SALICYLATE) METHYL SALICYLATE.060 kg  in 100 L
THYMOL (THYMOL) THYMOL.064 kg  in 100 L
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
BENZOIC ACID 
POLOXAMER 407 
CARAMEL 
Packaging
#Item CodePackage Description
1NDC:53942-318-861 L in 1 BOTTLE, PLASTIC
2NDC:53942-318-131.25 L in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/13/1989
Labeler - Demoulas Super Markets, Inc (007869647)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon790752542manufacture

Revised: 01/2011
Document Id: e9f4c05f-08cf-4ce0-ab91-127721a46205
Set id: 37e9f40c-dff3-4185-abad-889e97ee4fcf
Version: 1
Effective Time: 20110119
 
Demoulas Super Markets, Inc