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Anticavity Fluoride Rinse by Topco Associates LLC

Dosage form: rinse
Ingredients: SODIUM FLUORIDE 0.2mg in 1mL
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.

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

Warnings

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 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)

004.001/004AE

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) FLUORIDE ION0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
EDETATE CALCIUM DISODIUM 
CETYLPYRIDINIUM CHLORIDE 
EDETATE DISODIUM 
SODIUM ACID PYROPHOSPHATE 
POLOXAMER 407 
POLYSORBATE 80 
PROPYLENE GLYCOL 
D&C RED NO. 33 
SODIUM BENZOATE 
SODIUM PHOSPHATE 
SACCHARIN SODIUM 
SORBITOL 
WATER 
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUM (Bubble Gum Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:36800-004-44532 mL 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(36800-004)

 
Topco Associates LLC

← See all Anticavity Fluoride Rinse brands

Medically reviewed on Oct 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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