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Antiseptic Mouth Rinse by Onpoint, Inc

Medically reviewed on January 1, 2018

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: 51143-072

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

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.

Keep out of reach of children.  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, poloxamer 407, benzoic acid, flavoring, sodium saccharin, sodium citrate, citric acid, D+C yellow no. 10, FD+C green no.3

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

DISTRIBUTED BY ONPOINT, INC.
2 PARAGON DRIVE
MONTVALE, NJ 07645

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
500  mL (16.9 FL OZ)
ANTISEPTIC MOUTH RINSE 
eucalyptol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51143-072
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 (METHYL SALICYLATE) METHYL SALICYLATE.060 kg  in 100 L
THYMOL (THYMOL) THYMOL.064 kg  in 100 L
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
POLOXAMER 407 
BENZOIC ACID 
SACCHARIN SODIUM 
SODIUM CITRATE 
D&C YELLOW NO. 10 
FD&C GREEN NO. 3 
Packaging
#Item CodePackage Description
1NDC:51143-072-77.5 L in 1 BOTTLE, PLASTIC
2NDC:51143-072-861 L in 1 BOTTLE, PLASTIC
3NDC:51143-072-121.5 L in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/27/2009
Labeler - Onpoint, Inc (001367366)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon790752542manufacture

 
Onpoint, Inc

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Further information

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

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