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Alcohol Free Refreshing Mint by Vi-Jon

Medically reviewed on May 14, 2018

Dosage form: mouthwash
Ingredients: SODIUM FLUORIDE 10.41mg in 1mL
Labeler: Vi-Jon
NDC Code: 0869-0576

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

TEP

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

claims

Mountain

falls

anticavity

mouth rinse

Active ingredient

Sodium fluoride 0.0219% (0.01% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

´╗┐For this product

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 6 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
  • instruct children under 12 years of age in good rinsing habits (to minimze swallowing)
  • supervise children as necessary until capable of using without supervision
  • children under 6 years of age: consult a dentist or doctor

Inactive ingredients

water, glycerin, flavor, cetylpyridinium chloride, poloxamer 407, phosphoric acid, methylparaben, sodium saccharin, propylparaben, propylene glycol, disodium phosphate, blue 1

Claims

This rinse may cause temporary staining to the surface of teeth.  This is not harmful, and adequate brushing may prevent its occurrence.

disclaimer

This product is not manufactured or distributed by Procter & Gamble, distributor of Crest Pro-Health Advanced Anticavity Fluoride Mouthwash

Adverse Reactions

Manufactured by: Vi-Jon, Inc.,

St. Louis, MO 63117

Questions or Comments? 1-888-593-0593

Made in the USA with US and foreign parts.

576.000/576AB

principal display panel

mountain

falls

Compare to Crest

alcohol free

kills bad breath germs

multi action with fluoride

freshens breath

anticavity mouth rinse

refreshing mint

IMPORTANT: READ DIRECTIONS FOR PROPER USE

1 L (33.8 FL OZ)

ALCOHOL FREE REFRESHING MINT 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0869-0576
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION10.41 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
CETYLPYRIDINIUM CHLORIDE 
POLOXAMER 407 
PHOSPHORIC ACID 
METHYLPARABEN 
SACCHARIN SODIUM 
PROPYLPARABEN 
PROPYLENE GLYCOL 
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
1NDC:0869-0576-861000 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35503/15/2017
Labeler - Vi-Jon (790752542)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon790752542manufacture(0869-0576)

 
Vi-Jon

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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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