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 Retail Business 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% (0.02% 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, 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
Inactive Ingredient
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
Disclaimer
This product is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Fluoride Rinse
SEALED WITH PRINTED NECKBAND FOR YOR PROTECTION
Adverse Reactions
DISTRIBUTED BY:
American Sales Company
4201 Walden Avenue, Lancaster, NY 14086
Principal Display Panel
Compare to the Active Ingredients in ACT
CAREONE
ANTICAVITY
FLUORIDE
RINSE
MINT FLAVOR
- Strong Cavity Protection
IMPORTANT: Read directions for proper use
18 FL OZ (532 mL)
* Please review the disclaimer below.