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Name:Anticavity
Manufacturer:Mckesson
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

ANTICAVITY  - sodium fluoride rinse 
McKesson

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                                              Purpose
Sodium fluoride 0.05% (0.02% w/v fluoride ion)      Antivacity 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 under 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 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 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

Other information • store at room temperature

The ADA council on Scientific Affairs Acceptance of Sunmark Anticavity Fluoride Rinse is based on its finding that the product is effective in helpt to prevent and reduce tooth decay, when used as directed.
This product is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Fluoride Rinse.
Another Quality Product
Distributed By McKesson
One Post Street
San Francisco, CA 94104
Money Back guarantee
Please visit us at
www.sunmarkbrand.com

Compare to Act Anticavity Fluoride Rinse
NDC 49348-603-15
antivacity
fluoride
rinse
Alcohol Free
ADA
Accepted
American
Dental
Association
IMPORTANT:
READ DIRECTIONS
FOR PROPER USE
Strong cavity protection
MINT FLAVOR
18 FL OZ (532 mL)
image of product label


ANTICAVITY 
sodium fluoride rinse
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-603
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
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49348-603-15 0.532 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 08/17/2001

Labeler - McKesson (177667227)
Registrant - Vi Jon (790752542)
Establishment
Name Address ID/FEI Operations
Vi Jon 790752542 manufacture

Revised: 07/2010 McKesson



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


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