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Anticavity Fluoride Rinse by Topco Associates, LLC

Dosage form: mouthwash
Ingredients: SODIUM FLUORIDE 0.2mg in 1mL
Labeler: Topco Associates, LLC
NDC Code: 36800-213

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.

Alcohol Free Anticavity Fluoride Rinse

Active ingredient

Sodium Fluoride 0.05% (0.02% w/v fluoride ion)

Purpose

Anticavity Rinse

Use

aids in the prevention of dental cavities

Warning

for this product only

Keep out of reach of children

If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.

Directions
  • adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste.
  • remove cap
  • pour 10 milliliters (10 mL mark on inside of cap); do not fill above 10 mL mark
  • vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
  • do now 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 necessay until capable of using without supervision
  • children under 6 years of age: consult a dentist or doctor

other information
  • store at room temperature

inactive ingredients

water, sorbitol, menthol, methyl salicylate, flavor, cetylpyridinium chloride, sodium saccharin, poloxamer 407, polysorbate 20, propylene glycol, sodium phosphate, disodium phosphate, calcium disodium EDTA, disodium EDTA, sodium benzoate, potassium sorbate, benzyl alcohol, green 3, yellow 5

Disclaimer

This product is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Fluoride Rinse

Adverse reactions

DISTRIBUTED BY:TOCO ASSOCIATES LLC

7711 GROSS POINT ROAD, SKOKIE, IL 60077

TOCO VIJ310

QUESTIONS? 1-888-423-0139 topcare@topcare.com

213.002/213AE rev 2

principal display panel

TopCare

MINT

Antuicavity

Fluoride

Rinse

  • Strong cavity protection
  • Helps strengthen teeth
  • Helps prevent cavities
  • Freshens breath

COMPARE TO ACT

active ingredient

IMPORTANT: READ

DIRECTIONS FOR PROPER USE

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

18 FL OZ (532 mL)

ANTICAVITY FLUORIDE RINSE 
sodium fluoride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-213
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water 
sorbitol 
MENTHOL 
METHYL SALICYLATE 
CETYLPYRIDINIUM CHLORIDE 
SACCHARIN SODIUM 
poloxamer 407 
POLYSORBATE 20 
PROPYLENE GLYCOL 
SODIUM PHOSPHATE 
SODIUM PHOSPHATE, DIBASIC, MONOHYDRATE 
EDETATE CALCIUM DISODIUM 
EDETATE DISODIUM ANHYDROUS 
SODIUM BENZOATE 
POTASSIUM SORBATE 
BENZYL ALCOHOL 
FD&C GREEN NO. 3 
FD&C YELLOW NO. 5 
Packaging
#Item CodePackage Description
1NDC:36800-213-44532 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35510/20/2003
Labeler - Topco Associates, LLC (006935977)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon790752542manufacture(36800-213)

 
Topco Associates, LLC

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Medically reviewed on Mar 8, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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