ANTISEPTIC MOUTH RINSE - eucalyptol, menthol, methyl salicylate and thymol mouthwash 
Walgreens Co.

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 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

This rinse is not intended to replace brushing or flossing

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, poloxamer 407, benzoic acid, flavoring, sodium saccharin, sodium citrate, citric acid, D+C yellow, FD+C green no. 3

The ADA Council on Scientific  Affairs Acceptance of  W Spring 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

W
MOUTH
RINSE
ANTISEPTIC
Kills germs that cause bad breath,
plaque and the gum disease gingivitis
Spring Mint
ADA
Accepted
American
Dental
Association
2 LITER (67.6 FL OZ)
Compare to Listerine active ingredients
EASY GRIP BOTTLE
image of principal display panel

ANTISEPTIC MOUTH RINSE 
eucalyptol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0072
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (EUCALYPTOL) EUCALYPTOL0.092 kg  in 100 L
MENTHOL (MENTHOL) MENTHOL0.042 kg  in 100 L
METHYL SALICYLATE (METHYL SALICYLATE) METHYL SALICYLATE0.060 kg  in 100 L
THYMOL (THYMOL) THYMOL0.064 kg  in 100 L
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
POLOXAMER 407 
BENZOIC ACID 
SODIUM CITRATE 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (Spring Mint) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0363-0072-770.5 L in 1 BOTTLE, PLASTIC
2NDC:0363-0072-861 L in 1 BOTTLE, PLASTIC
3NDC:0363-0072-121.5 L in 1 BOTTLE, PLASTIC
4NDC:0363-0072-131.25 L in 1 BOTTLE, PLASTIC
5NDC:0363-0072-882 L in 1 BOTTLE, PLASTIC
6NDC:0363-0072-69.25 L in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/30/2007
Labeler - Walgreens Co. (008965063)
Registrant - Vi Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon790752542manufacture

Revised: 11/2010
Document Id: 5f94120c-54fb-4e0f-b46b-295474434b07
Set id: cba60e9d-5f12-4c56-9fa5-6ce1514fc2b0
Version: 1
Effective Time: 20101109
 
Walgreens Co.