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Name:Anticavity Fluoride Rinse
Manufacturer:Topco Associates, Llc
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

ANTICAVITY FLUORIDE RINSE  - sodium fluoride mouthwash 
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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Drug Facts

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

Purpose
Anticavity rinse

Use aids in the prevention of dental cavities

Warning

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 the inside of cap); do not fill above the 10 mL mark
• vigorously swish 10 milliliters 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

Other information • store at room temperature

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

The ADA Council on Scientific Affairs Acceptance of Western Family Anticavity Fluoride rinse is based on its finding that the product is effective in helping to prevent and reduct tooth decay, when used as directed.

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  topcare@topco.com

MINT
Alcohol Free
Anticavity
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)
image of principal display panel


ANTICAVITY FLUORIDE RINSE 
sodium fluoride mouthwash
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-213
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 0.05 kg  in 100 L
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL  
CETYLPYRIDINIUM CHLORIDE  
MENTHOL  
METHYL SALICYLATE  
POLOXAMER 407  
POLYSORBATE 20  
POTASSIUM SORBATE  
PROPYLENE GLYCOL  
SODIUM BENZOATE  
SODIUM PHOSPHATE  
SORBITOL  
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36800-213-44 .532 L in 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 10/20/2003

Labeler - Topco Associates, LLC (006935977)
Registrant - Vi-Jon (790752542)
Establishment
Name Address ID/FEI Operations
Vi-Jon 790752542 manufacture

Revised: 01/2011 Topco Associates, LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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