ANTISEPTIC MOUTH RINSE - eucalyptol mouthwash 
Vi-Jon

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 0.042%
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

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

Distributed by:
Vi-Jon
St. Louis, Missouri 63114
Questions 1-888-593-0593

Child-Resistant Cap
SEALED WITH PRINTED NECKBAND
FOR YOUR PROTECTION
Amber
Antiseptic
Mouth Rinse
Kills germs that cause Plaque,
Gingivitis and Bad Breath
1.5 L (50.7 FL OZ)
image of principal display panel


ANTISEPTIC MOUTH RINSE 
eucalyptol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11344-318
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL.092 kg  in 100 L
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL.042 kg  in 100 L
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE.060 kg  in 100 L
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL.064 kg  in 100 L
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
CARAMEL (UNII: T9D99G2B1R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11344-318-861 L in 1 BOTTLE, PLASTIC
2NDC:11344-318-69.25 L in 1 BOTTLE, PLASTIC
3NDC:11344-318-121.5 L in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/04/2001
Labeler - Vi-Jon (150931459)
Registrant - Vi-Jon (150931459)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon150931459manufacture

Revised: 1/2011
Document Id: defbe48f-2b1c-417e-9ccc-1e90988de31f
Set id: 5b9c19a1-e3c0-4bed-92dd-8bff48477e2e
Version: 1
Effective Time: 20110119
 
Vi-Jon