FDA Label for Anticavity Rinse
View Indications, Usage & Precautions
Anticavity 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
Warnings
for this product
Keep Out Of Reach Of Children.
If more than used for rinsing is accidentally swallowed, seep 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 inside of cap); do not fill above the 10mL 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, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water
Other Information
- store at room temperature
Claims
Sealed with printed neckband for your protection
*This product is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Fluoride Rinse.
"The ADA council on Scientific Affairs Acceptance of Meijer Kids Anticavity Fluoride Rinse is based on the finding that the product is effective in
helping to prevent and reduce tooth decay, when used as directed."
Adverse Reactions
Distributed by Meijer Distribution, Inc.
Grand Rapids, MI 49544
www.meijer.com
004.002/004AE
Principal Display Panel
Compare to Act active ingredient
NDC 41250-004-44
meijer
kids!
anticavity fluoride rinse
alcohol free
Bubble Gum
ADA
Accepted
American
Dental
Association
IMPORTANT: read directions for proper use
18 FL OZ (532 mL)
* Please review the disclaimer below.