ANTISEPTIC MOUTH RINSE - eucalyptol, menthol, methyl salicylate and thymol mouthwash 
Wakefern Food Corporation

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
Antigingivitis, 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
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
•this rinse is not intended to replace brushing or flossing

Other information cold weather may cloud this product.  Its antiseptic properties are not affected.  Store at room temperature (59⁰ - 77⁰F)

Inactive ingredients water, alcohol 21.6%, sorbitol solution, poloxamer 407, benzoic acid, flavoring, sodium saccharin, sodium citrate, citric acid, D+C yellow no. 10, FD+C green no.3

The ADA Council on Scientific Affairs Acceptance of ShopRite Fresh Mint Antiseptic Mouth Rinse
is based on its finding that the product is effective in helping to prevent and reduce gingivitis and
plaque above the gumline, when used as directed
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:
WAKEFERN FOOD CORPORATION
5000 RIVERSIDE DRIVE
KEASBEY, NJ 08832
1-800-SHOPRITE
www.shoprite.com

Compare to the Active Ingredients of LISTERINE
ShopRite
ANTISEPTIC
MOUTH RINSE
Helps to kill germs that cause plaque,
gingivitis and bad breath.
FRESH MINT
ADA
Accepted
American
Dental
Association
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:41190-072
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 
POLOXAMER 407 
BENZOIC ACID 
SACCHARIN SODIUM 
SODIUM CITRATE 
D&C YELLOW NO. 10 
FD&C GREEN NO. 3 
Packaging
#Item CodePackage Description
1NDC:41190-072-861 L in 1 BOTTLE, PLASTIC
2NDC:41190-072-131.25 L in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/28/1999
Labeler - Wakefern Food Corporation (069722418)
Registrant - Vi-Jon (790752542)

Revised: 02/2011
Document Id: eb763240-bc50-41d7-8edc-0eb5a9392f77
Set id: 7a9f7eeb-78ae-4e7e-9a65-ee127786e245
Version: 1
Effective Time: 20110201
 
Wakefern Food Corporation