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Anticavity Fluoride Rinse by Topco Associates LLC

Medically reviewed on October 6, 2017

Dosage form: rinse
Ingredients: SODIUM FLUORIDE .05kg in 100L
Labeler: Topco Associates LLC
NDC Code: 36800-004

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.

Drug Facts

Active ingredients
Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Purpose
Anticavity rinse

Use aids in the prevention of dental cavities

Warning

Enter section text here

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 milliters (10 mL mark on inside of cap): do not fill above the 10 mL mark 
• vigorously swish 10 milliliters 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)
• 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

Other information • store at room temperature

Inactive ingredients benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

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

Distributed by: TOPCO ASSOCIATES LLC
7711 GROSS POINT ROAD, SKOKIE, IL 60077
QUESTIONS? 1-888-423-0139

Children's
Alcohol Free
ANTIVACITY
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 rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-004
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE.05 kg  in 100 L
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
CETYLPYRIDINIUM CHLORIDE 
POLOXAMER 407 
PROPYLENE GLYCOL 
SODIUM PHOSPHATE 
SORBITOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUM (Bubble Gum Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:36800-004-44.5 L in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35504/08/2004
Labeler - Topco Associates LLC (006935977)
Registrant - Vi Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi Jon790752542manufacture

 
Topco Associates LLC

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Further information

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

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