MOUTH RINSE- eucalyptol, menthol, methyl salicylate, thymol mouthwash

Mouth Rinse by

Drug Labeling and Warnings

Mouth Rinse by is a Otc medication manufactured, distributed, or labeled by Onpoint, Inc, Vi-Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

MOUTH RINSE 
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51143-318
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK)	EUCALYPTOL	0.92 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.42 mg  in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.60 mg  in 1 mL
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	0.64 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
BENZOIC ACID (UNII: 8SKN0B0MIM)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARAMEL (UNII: T9D99G2B1R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51143-318-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/27/2009
2	NDC: 51143-318-12	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/27/2009
3	NDC: 51143-318-77	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/27/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/27/2009

Labeler - Onpoint, Inc (001367366)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(51143-318)