ANTISEPTIC - eucalyptol mouthwash 
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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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Drug Facts

Active ingredients
Eucalyptol 0.092%  Menthol 0.024%
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 guns, 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 propertied are not affected.  Store at room temperature (59⁰-77⁰F).

Inactive ingredients water, alcohol (21.6%), sorbitol solution, flavoring, PEG-40 hydrogenated castor oil, poloxamer 407, benzoic acid, zinc chloride, sucralose and/or sodium saccharin, sodium benzoate, yellow 6, red 40

This product is not manufactured or distributed by Johnson + Johnson Healthcare Products, distributor of Listerine
DSP-TN-15000
DSP-MO-34
SDS-TN-15012

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ANTISEPTIC
MOUTH RINSE
TARTAR CONTROL CITRUS
Compare to Citrus Advanced Listerine with Tartar Protection
Kills germs that cause Bad Breath, Plaque + the gum disease Gingivitis
Improves Oral hygiene
Helps control tartar that can discolor teeth
Sealed with printed neckband for your protection
1 L (33.8 FL OZ)
image of principal display panel
ANTISEPTIC 
eucalyptol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55301-210
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL.092 mL  in 100 L
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL.042 mL  in 100 L
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE.060 mL  in 100 L
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL.064 mL  in 100 L
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
SORBITOL (UNII: 506T60A25R)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55301-210-861 L in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35610/18/2010
Labeler - Exchange Select (001695568)
Registrant - Vi Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon790752542manufacture

Revised: 3/2012
Document Id: c28e412b-16f0-456a-ad18-a57a256f40b6
Set id: e32aa65b-ad9c-4d22-9a6c-0c8aca983e2d
Version: 1
Effective Time: 20120326
 
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