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

Antispetic Mouth Rinse by

Drug Labeling and Warnings

Antispetic 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

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

disclaimer

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

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Adverse reactions

Distributed by

Onpoint, Inc 

2 Paragon Drive

Montvale, NJ 07645

124.002/124AC

permits

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

principal display panel

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Live Better

Antiseptic

MOUTH RINSE

VANILLA MINT

Compare to Active Ingredients

in Vanilla Mint Listerine

KILLS GERMS THATCAUSE

• BAD BREATH,
• PLAQUE
• GINGIVITIS

GUM DISEASE

1L (33.8 FL OZ)

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51143-124-77	.5 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/16/2010
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/16/2010

Labeler - Onpoint, Inc (001367366)

Registrant - Vi Jon (790752542)

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