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 Amazon. Com Services Llc. 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% (0.2% 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, seek professional assistance or contact a Poison Control Center immediately.
Directions
- adults and children 6 year 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 year 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
Adverse Reactions
The ADA Council on Scientific Affairs' Acceptance of Publix Kids 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.
Sealed with printed neckband for your protection
*This product is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Fluoride Rinse.
Distributed by Publix Super Markets, Inc.
3300 Publix Corporate Parkway
Lakeland, FL 33811
publix.com
004.002/004AE
Principal Display Panel
Solimo
Kids Anticavity Fluoride Rinse
Bubble gum
Alcohol free
IMPORTANT: RAD DIRECTIONS FOR PROPER USE
16.9 FL OZ (500 mL)
* Please review the disclaimer below.