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Antispetic Mouth Rinse

Dosage form: mouthwash
Ingredients: EUCALYPTOL .092kg in 100L, MENTHOL .042kg in 100L, METHYL SALICYLATE .060kg in 100L, THYMOL .064kg in 100L
Labeler: Onpoint, Inc
NDC Code: 51143-124

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.

Drug Facts

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)

ANTISPETIC MOUTH RINSE 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51143-124
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (EUCALYPTOL) EUCALYPTOL.092 kg  in 100 L
MENTHOL (MENTHOL) MENTHOL.042 kg  in 100 L
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE.060 kg  in 100 L
THYMOL (THYMOL) THYMOL.064 kg  in 100 L
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
POLOXAMER 407 
BENZOIC ACID 
SUCRALOSE 
SODIUM BENZOATE 
PROPYLENE GLYCOL ALGINATE 
Packaging
#Item CodePackage Description
1NDC:51143-124-77.5 L in 1 BOTTLE, PLASTIC
2NDC:51143-124-861 L in 1 BOTTLE, PLASTIC
3NDC:51143-124-121.5 L in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/16/2010
Labeler - Onpoint, Inc (001367366)
Registrant - Vi Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi Jon790752542manufacture(51143-124)

 
Onpoint, Inc

Medically reviewed on Jul 30, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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