Antiseptic Mouth Rinse by Onpoint, Inc / Vi-Jon Drug Facts   072

Antiseptic Mouth Rinse by

Drug Labeling and Warnings

Antiseptic 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]

ANTISEPTIC MOUTH RINSE- eucalyptol 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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Drug Facts   072

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.

Stop use and ask a dentist if

 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 or flossing

Other information

cold weather may cloud this product.  Its antiseptic properties are not affected.  Store at room temperature (59⁰ - 77⁰F)

Inactive ingredients

water, alcohol 21.6%, sorbitol {solution}, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate, D&C yellow no. 10, FD&C green no. 3

ADA statement

The ADA Council on Scientific Affairs Acceptance of Live Better Fresh Mint Antiseptic Mouth Rinse is based on it finding that the product is effective  in helping to prevent and reduct gingivitis and plaque above the gumline, when used as directed.

DSP-TN-15000, DSP-MO-34, SDS-TN-15012

Adverse reaction

DISTRIBUTED BY ONPOINT, INC.

2 PARAGON DRIVE

MONTVALE, NJ 07645

072.002/072AL

principal display panel

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

LIVE bETTER

ADA

Accepted

American

Dental

Association

Antiseptic

Mouth

Rinse

FRESH MINT

• KILLS GERMS THAT CAUSE BAD BREATH, PLAQUE, GINGIVITIS GUM DISEASE

500mL (16.9 FL OZ)

ANTISEPTIC MOUTH RINSE 
eucalyptol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51143-072
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)
SORBITOL (UNII: 506T60A25R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51143-072-77	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/27/2009	03/02/2020
2	NDC: 51143-072-86	1000 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package	07/27/2009	03/02/2020
3	NDC: 51143-072-12	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/27/2009	03/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/27/2009	03/02/2020

Labeler - Onpoint, Inc (001367366)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(51143-072)

Revised: 3/2020

Document Id: f602ba4f-44c0-4977-b5bd-962cf9086cbb

34390-5

Set id: bcbed445-a0ff-4cb5-83c1-94a4d8374808

Version: 5

Effective Time: 20200303

 

Onpoint, Inc