ANTISPETIC 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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Mouthrinse
124

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

Stop use and ask a dentist if

• gingivitis, bleeding, or redness persists for more than 2 weeks
• you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. These may be signs of periodontitis, a serious form of gum disease.

Keep out of reach of children under 6 years of age.

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 teaspoofuls) between your teeth twice a day for 30 seconds
then spit out. Do not swallow the rinse
• children 6 years to under 12 years of age: supervise use
• children under 6 years of age: do not sue

Other Information

• this rinse is not intended to replace the brushing or flossing
• cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59⁰-77⁰ F)

Inactive ingredients

water, alcohol (21.6%) sorbitol solution, flavor, poloxamer 407, benzoic acid, sucralose and/or sodium saccharin, sodium benzoate, propylene glycol alginate, FD+C yellow no. 6, FD+C blue no. 1

*This product is not manufactured or distributed by Johnson + Johnson Healthcare products, distributor of Listerine.

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

Distributed by
Onpoint, Inc
2 Paragon Drive
Montvale, NJ 07645

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SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Live Better

Antiseptic

MOUTH RINSE

VANILLA MINT

Compare to Active Ingredients in Vanilla Mint Listerine

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

1L (33.8 FL OZ)

image description

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51143-124
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK)	EUCALYPTOL	.092 kg in 100 L
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	.042 kg in 100 L
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	.060 kg in 100 L
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	.064 kg in 100 L

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
POLOXAMER 407 (UNII: TUF2IVW3M2)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PROPYLENE GLYCOL ALGINATE (UNII: 26CD3J2R0C)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51143-124-77	.5 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/16/2010	06/10/2021
2	NDC:51143-124-86	1 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/16/2010
3	NDC:51143-124-12	1.5 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/16/2010

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	07/16/2010	06/10/2021

Labeler - Onpoint, Inc (001367366)

Registrant - Vi Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi Jon, LLC		790752542	manufacture(51143-124)

Revised: 6/2021

Document Id: 2fe47457-f208-4ee8-9570-c4f3f60c4811

Set id: 74981c49-de11-4d60-b11d-3bb1f9b26cdf

Version: 12

Effective Time: 20210610

Onpoint, Inc

Mouthrinse124