ANTICAVITY FLUORIDE RINSE- anticavity fluoride  mouthwash 
Vi Jon

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.

----------

Anticavity Fluoride Rinse
893

Active ingredient

Sodium fluoride 0.0221% (0.01% 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, seek professional assistance or contact a Poison Control Center right away.

Directions

•adults and children 6 years of age and older: use twice a day after brushing your teeth with toothpaste

•remove cap

•pour 10 milliliters (10 mL mark on inside of cap); do not fill about 10 mL mark

•vigorously swish 10 milliliter of rinse between your teeth for 1 minute and then spit out

•do not sallow the rinse

•do not eat or drink 30 minute after rinsing

•instruct children under 12 years of age in good rinsing habits (to minimize swallowing)

•supervise children as necessary until capable of using without supervision

•children under 6 years of age: consult a dentist or doctor

Other information

store at 20⁰ to 25⁰ C (68⁰ to 77⁰ F)

Inactive ingredients

water, sorbitol solution, propylene glycol, flavors, phosphoric acid, sucralose, cetylpyridinium chloride, disodium phosphate, methylparaben, propylparaben, red 40, green 3

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

ALCOHOL FREE ANTIVACITY Fluoride Rinse

berry

•Kills Germs that Cause Bad Breath

•Helps Prevent Cavities

•See proof in Your Sink of a Cleaner Mouth! Contains Ingredients that Tint Food Particles.

16.9 FL OZ (500 mL)

IMPORTANT: Read directions for proper use.

image of principal display panel

ANTICAVITY FLUORIDE RINSE 
anticavity fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0869-0893
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE.0221 kg  in 100 L
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
PARAMETHASONE DISODIUM PHOSPHATE (UNII: 41I31208JK)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
Product Characteristics
Color    Score    
ShapeSize
FlavorSTRAWBERRY (berry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0869-0893-77.5 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/16/200906/16/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/16/200906/16/2015
Labeler - Vi Jon (790752542)
Registrant - Vi Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon790752542manufacture(0869-0893)

Revised: 5/2020
 
Vi Jon