Your browser does not support JavaScript! ALCOHOL-FREE ANTICAVITY (SODIUM FLUORIDE) LIQUID [MEIJER DISTRIBUTION, INC]
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ALCOHOL-FREE ANTICAVITY (sodium fluoride) liquid
[Meijer Distribution, Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

Claims

Sealed with printed neckband for your protection

Claims

Promotes fresh breath while fighting cavities

Alcohol-free formula will not burn as it helps kill germs

Active ingredients

Active Ingredient

Sodium fluoride 1.1219% (0.0 w/v fluoride ion)

Purpose

Purpose

Anticavity

Use

Use aids in the preveiontion of dental cavities

Warning

Warning

Keep out of reach of children

Keep our 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

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

Inactive ingredients water, glycerin, flavor, cetylpyridinium chloride, phosphoric acid, methylparaben, sodium saccharin, poloxamer 407, propylparaben, propylene glycol, disodium phosphate, red 33, green3

Claims

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

Dislcaimer

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

Adverse Reaction

DISTRIBUTED BY

MEIJER DISTRIBUTION, INC.

2929 WALKER AVE NW

GRAND RAPIDS, MI 49544

www.meijer.com

Principal Display panel

Meijer

Alcohol-Free

ANTICAVITY

FLUORIDE MOUTH RINSE

  • Helps prevent cavities
  • Helps strengthen enamel
  • Helps clean the entire mouth
  • Helps kiss germs that cause bad breath
  • No alcohol burn

VIOLET MINT

IMPORTANT: read directiosn for proper use

1 L (33.8 FL OZ)

image description

ALCOHOL-FREE ANTICAVITY 
sodium fluoride liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41250-482
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water 
GLYCERIN 
CETYLPYRIDINIUM CHLORIDE 
PHOSPHORIC ACID 
METHYLPARABEN 
SACCHARIN SODIUM DIHYDRATE 
POLOXAMER 407 
PROPYLPARABEN 
PROPYLENE GLYCOL 
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 
D&C RED NO. 33 
FD&C GREEN NO. 3 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41250-482-861000 mL in 1 BOTTLE, PLASTIC
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: 10/2012
 
Meijer Distribution, Inc

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