FDA Label for Anticavity Fluoride Rinse

View Indications, Usage & Precautions

Anticavity Fluoride Rinse Product Label

The following document was submitted to the FDA by the labeler of this product Meijer Distribution, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


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 childre 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 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



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


Other Information



• store at room temperature


Questions



Call 1-888-593-0593


Disclaimer



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


Safety Seal



SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION


Ada Council



"The ADA Council on Scientific Affairs Acceptance of Meijer Anticavity Fluoride Rinse is based on its finding that the product is effective in helping to prevent and reduce tooth decay, when used as directed."


Adverse Reactions



DISTRIBUTED BY

MEIJER DISGRIBUTION, INC

GRAND RAPIDS, MI 49544

www.meijer.com

213.002/213AE rev 2


Principal Display Panel



NDC 41250-213-44

Compare to

Act

active ingredient

meijer

Fresh Mint

Anticavity

Fluoride Rinse

Alcohol Free

Helps prevent cavities

Helps strengthen teeth

Freshens breath

ADA

Accepted

American

Dental

Association

IMPORTANT:

read directions

for proper use

18 FL OZ (532 mL)


* Please review the disclaimer below.