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Mouth Rinse by Onpoint, Inc

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: Onpoint, Inc
NDC Code: 51143-318

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

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 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

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 of flossing


Other information

cold weather may cloud this product.  Its antiseptic properties are not affected.  Store at room temperature (57⁰-77⁰F)

inactive ingredints

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

adverse reactions

DISTRIBUTED BY

ONPOINT, INC

2PARAGON DR

MONTVALE, NJ 07645

318.003/318AH

claims

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

The ADA Council on Scientific Affairs Acceptance of CVD/pharmacy Antiseptic Mouth rinse is based on the finding

that the product is effective in helping to prevent and reduct gingivitis and plaque above the gumline, when used as directed.

Live Better product provide a simple way to look after yourself and your family.  All of our product are crafted from 

high quality ingredients to exacting standards.  Live Better is a great way to meet the health needs of your busy lifestyle.  Live Better helps you be better.

Live Better, for life.

Principal Display Panel

LiveBetter 

Antiseptic

Mouth Rinse

ORIGINAL

KILLS GERMS THAT CAUSE BAD BREATH PLAQUE, GINGIVITIS GUM DISEASE

ADA

Accepted

American

Dental

Association

1L (33.8 FL OZ)

MOUTH RINSE 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51143-318
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:51143-318-861000 mL in 1 BOTTLE, PLASTIC
2NDC:51143-318-121500 mL in 1 BOTTLE, PLASTIC
3NDC:51143-318-77500 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/27/2009
Labeler - Onpoint, Inc (001367366)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon790752542manufacture(51143-318)

 
Onpoint, Inc

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Medically reviewed on Apr 12, 2018

Further information

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

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