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Antiseptic Mouth Rinse by Chain Drug Consortium

Medically reviewed on Apr 16, 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: Chain Drug Consortium
NDC Code: 68016-318

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

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 children

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Directions

Adult and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonsful) 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 (59° - 77°F) 

Inactive ingredients

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

ADA Statement

"The ADA council on Scientific Affairs  Acceptance of Premier Value Original 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."

Disclaimer

This product is not manufactured or directed by Johnson & Johnson Healthcare Poroducts, distributor of Original Listerine Antiseptic Mouthwash

Adverse Reactions

DISTRIBUTED BY

CHAIN DRUG CONSORTIUM

3301 NW BOCA RATON BLVD

SUITE 101, BOCA RATON, FL 33431

318.003/318AH

Package label

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

COMPARE TO ORIGINAL LISTERINE ANTISEPTIC MOUTHWASH

Premier

Value

Antiseptic

Mouthrinse

Antigingivitis/Antiplaque

original

kills germs that cause

bad breath, plaque & the

gum disease gingivitis

ADA

Accepted

American

Dental

Association

1 L (33.8 FL OZ)

ANTISEPTIC MOUTH RINSE 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-318
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:68016-318-861000 mL in 1 BOTTLE, PLASTIC
2NDC:68016-318-77500 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35608/19/2003
Labeler - Chain Drug Consortium (101668460)
Registrant - Vi-Jon (150931459)
Establishment
NameAddressID/FEIOperations
Vi-Jon150931459manufacture(68016-318)

 
Chain Drug Consortium

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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