Anticavity Fluoride Rinse

Anticavity Fluoride Rinse

Drug Labeling and Warnings

Drug Details

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ALCOHOL-FREE ANTICAVITY- sodium fluoride liquid 
Meijer Distribution, Inc

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.

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Anticavity Fluoride Rinse

Active ingredient

Sodium fluoride 0.02% (0.01 w/v fluoride ion)

Purpose

Anticavity

Use

aids in the preveiontion 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 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 minimize 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, cetylpyridinium chloride, flavor, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, red 33, green 3

Sealed with printed neckband for your protection

Promotes fresh breath while fighting cavities
Alcohol-free formula will not burn as it helps kill germs

*Ths product is not manufactured or distributed by Procter + Gamble, distributor of Crest Pro-Health Complete Anticavity Fluoride Rinse.

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

DISTRIBUTED BY

MEIJER DISTRIBUTION, INC.

2929 WALKER AVE NW

GRAND RAPIDS, MI 49544

www.meijer.com

Principal Display panel

*Compare to Crest Pro-Heaalth Complete active ingredient

Meijer

Vilolet Mint

FLUORIDE MOUTH RINSE

Anticavity

6 Benefits:

  • Kills bad breath germs
  • Helps prevent cavities
  • Helps strengthen enamel
  • Cleans teeth
  • Freshens breath
  • Alcohol free

IMPORTANT: read directiosn for proper use

1 L (33.8 FL OZ)

image description

482.001/482AB

ALCOHOL-FREE ANTICAVITY 
sodium fluoride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 41250-482
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 41250-482-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/22/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35502/22/2012
Labeler - Meijer Distribution, Inc (006959555)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon790752542manufacture(41250-482)

Revised: 12/2018
 
Meijer Distribution, Inc


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