FDA Label for Fluoride Mouth Rinse Anticavity
View Indications, Usage & Precautions
Fluoride Mouth Rinse Anticavity Product Label
The following document was submitted to the FDA by the labeler of this product Target Corp.. 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
Warnings
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 toothpaste
- remove cap
- pour 10 milliliters (10 mL mark on 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 it 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 childrenas necessary until capable of using without supervision
- children under 6 years of age: consult a dentist or doctor
Other Information
store at room temperature
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
The ADA Council on Scientific Affairs Acceptance of up & up mint anticativity fluoride rinse is based on its finding that the product is effective in helping to prevent and reduce tooth decay, when used as directed
*This product is not manufactured or distributed by Chattem, Inc., distributor of Act
Dist. by Target Corp., Mpls., MN 55403
Made in U.S.A. with U.S. and foretign components
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SAFETY SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
ANTICAVITY
fluoride mouthrinse
*Compare to Act Anticavity Fluoride Rinse
helps prevent cavities
helps strengthen teeth
freshens breath
up & up
Mint Flavor
IMPORTANT: read directions for proper use
18 fl oz (532 mL)
* Please review the disclaimer below.