Anticavity Fluroide Rinse

Anticavity Fluroide Rinse

Drug Labeling and Warnings

Drug Details

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ALCOHOL-FREE ANTICAVITY- sodium fluoride liquid 
Wal-Mart Stores, 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 Fluroide Rinse

Active ingredient

Sodium fluoride 0.0219% (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, 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 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, flavor, cetylpyridinium chloride, phosphoric acid, methylparaben, sodium saccharin, poloxamer 407, propylparaben, propylene glycol, disodium phosphate, red 33, green 3

Questions

Call 1-888-287-1915

Alcohol Free Anticavity Oral Rinse

Sealed with printed neckband for your protection

*This product is not manuractured 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 burshing may prevent it occurence.
Satisfaction guaranteed-Or we'll replace it or give you your money back. For questions or comments or to report and undesired reaction or side effect, please call 1-888-287-1915

Distributed by:Wal-Mart Stores, Inc., Bentonville, AR 72716

Principal Display Panel

Equate

Compare to Crest Pro Health Rinse Active Ingredient*

IMPORANT: READ DIRECTIONS FOR PROPER USE

Alcohol Free Anticavity Oral Rinse

Multi-Action with Fluoride

  •  Strengthens enamel
  • Helps Prevent cavities
  • Cleans teeth
  • Kills bad breath germs
  • Helps keep mouth feeling clean
  • Freshens Breath
  • No burn alcohol

Mint

1 L (33.8 FL OZ)

image description

482.000/482AA

ALCOHOL-FREE ANTICAVITY 
sodium fluoride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 49035-482
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)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 49035-482-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/27/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/27/2013
Labeler - Wal-Mart Stores, Inc (051957769)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon790752542manufacture(49035-482)

Revised: 12/2018
 
Wal-Mart Stores, Inc


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