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Anticavity by Onpoint, Inc

Medically reviewed on March 26, 2018

Dosage form: mouthwash
Ingredients: SODIUM FLUORIDE .0221mL in 100L
Labeler: Onpoint, Inc
NDC Code: 51143-966

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
Sodium fluoride 0.221%(0.021% w/v fluoride ion)

Purpose
Anticavity

Use aids in the prevention of dental cavities

Warnings

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:
•use twice daily after brushing your teeth with a toothpaste
•vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
•do not swallow the rinse
•do not eat or drink for 30 minutes after rinsing
•supervise children as necessary until capable of using without supervision
•children under 12 years of age: consult a dents or doctor

Other information
•store at controlled room temperature 20⁰ - 25⁰ C (68⁰ - 77⁰F)
•cold weather may temporarily cloud this product

Inactive ingredients water, sorbitol solution; alcohol (21.6%), flavors, poloxamer 407, sodium lauryl sulfate, phosphoric acid, sucralose and /or sodium saccharin,
diabasic sodium phosphate, D+C red no.33, FD+C blue no.1, FD+C yellow no.6

This product is not manufactured or distributed by Johnson + Johnson Healthcare products, distributor of Listerine Total Care
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
Anticavity
Mouthwash
Sodium Fluoride and Acidulated
Phosphate Topical Solution
ICE MINT
Compare to Active Ingredients in Listerine Total Care
•HELPS PREVENT CAVITIES
•RESTORES ENAMEL
•HELPS STRENGTHEN TEETH
•HELPS KILL GERMS THAT CAUSE BAD BREATH
•FRESHENS BREATH
IMPORTANT: READ DIRECTIONS FOR PROPER USE.
1L (33.8 FL OZ)
ANTICAVITY 
sdoium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51143-966
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE.0221 mL  in 100 L
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITOL 
ALCOHOL 
POLOXAMER 407 
SODIUM LAURYL SULFATE 
PHOSPHORIC ACID 
SUCRALOSE 
SODIUM PHOSPHATE, DIBASIC 
D&C RED NO. 33 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 6  
Packaging
#Item CodePackage Description
1NDC:51143-966-861 L in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35503/21/2012
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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