Anticavity Fluoride Rinse

Anticavity Fluoride Rinse

Drug Labeling and Warnings

Drug Details

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ALCOHOL-FREE ANTICAVITY- sodium fluoride liquid 
TOPCO Associates LLC

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 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, 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

Topcare everyday

  • Helps strengthen enamel
  • Helps prevent cavities
  • Kills bad breath germs
  • Freshens breath

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

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

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

1-888-423-0139  [email protected] www.topcarebrand.com

Principal Display Panel

Coompare to Crest Pro-Health Advanced Anticavity Fluoride Mouthwash*

Topcare everyday

Alcohol free Fluoride Anticavity Mouthwash

Violet mint

  • Helps strengthen enamel
  • Helps prevent cavities
  • Helps keep mouth feeling clean
  • Kills bad breath germs
  • Freshens breath

IMPORTANT: read directions for proper use.

33.8 FL OZ (1 QT 1.8 FL OZ ) 1 L

image description

482.001/482AB

ALCOHOL-FREE ANTICAVITY 
sodium fluoride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 36800-482
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.219 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: 36800-482-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/19/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/19/2013
Labeler - TOPCO Associates LLC (006935977)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon790752542manufacture(36800-482)

Revised: 12/2018
 
TOPCO Associates LLC


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