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Antiseptic Mouth Rinse by GREENBRIER INTERNATIONAL, INC.

Medically reviewed on February 7, 2018

Dosage form: mouthwash
Ingredients: EUCALYPTOL 0.92mg in 1mL, MENTHOL 0.42mg in 1mL, METHYL SALICYLATE 0.60mg in 1mL, THYMOL 0.64mg in 1mL
Labeler: GREENBRIER INTERNATIONAL, INC.
NDC Code: 33992-0318

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.


Drug Facts

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

For this product

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 chrildren

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 twice a day 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 (59°-77°F).

Inactive ingredients

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

Disclaimer

This product is not manufactued or distributed by Johnson & Johnson Healthcare Products, distributor of Original Listerine Antiseptic Mouthwash.

Adverse reaction

DISTRIBUTED BY

GREENBRIER INTERNATIONAL, INC.

500 VOLVO PARKWAY

CHESAPEAKE, VA 23320

DSP-TN-1500

DSP-MO-34

SDS-TN-15012

318.002/318AH

principal display panel

COMPARE TO ACTIVE INGREDIENTS OF LISTERINE

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

ASSURED

ORIGINAL

MOUTH

RINSE

ANTISEPTIC

Kills Germs That Cause Bad Breath, Plaque and the Gum Disease Gingivitis

16.9 FL OZ (500 mL)

318.003/318AH

ANTISEPTIC MOUTH RINSE 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0318
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (EUCALYPTOL) EUCALYPTOL0.92 mg  in 1 mL
MENTHOL (MENTHOL) MENTHOL0.42 mg  in 1 mL
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE0.60 mg  in 1 mL
THYMOL (THYMOL) THYMOL0.64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
BENZOIC ACID 
POLOXAMER 407 
SODIUM BENZOATE 
CARAMEL 
Packaging
#Item CodePackage Description
1NDC:33992-0318-7500 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35602/09/2017
Labeler - GREENBRIER INTERNATIONAL, INC. (610322518)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon790752542manufacture(33992-0318)

 
GREENBRIER INTERNATIONAL, INC.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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