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

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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Live Better 318

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)

image description

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51143-318-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/27/2009	07/17/2020
2	NDC:51143-318-12	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/27/2009	07/17/2020
3	NDC:51143-318-77	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/27/2009	07/17/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	07/27/2009	07/17/2020

Labeler - Onpoint, Inc (001367366)

Registrant - Vi-Jon (790752542)

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

Revised: 7/2020

Document Id: 2d7721e6-3411-43c2-adc6-941714c5198c

Set id: 4c7fe3f9-b533-4994-a451-d6a1d80dbcdb

Version: 4

Effective Time: 20200717

Onpoint, Inc