Otc - Active Ingredient
Active ingredient Purpose
Sodium fluoride 0.05% (0.02%w/v fluoride ion) Anticavity rinse
Anticavity Fluoride Rinse Mouthwash
FDA Label NDC 59779-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc. for the product Anticavity Fluoride Rinse (NDC 59779-004). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, indications & usage, warnings, dosage & administration, inactive ingredient, user safety warnings, other, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
Use aids in the prevention of dental cavities
Warnings
WarningKeep out of reach of children. If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.
Dosage & Administration
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 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 years of age: consult a dentist or doctor
Inactive Ingredient
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
User Safety Warnings
Sealed with printed neckband for your protection
Other
This product is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Fluorde Rinse.
Distributed by CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
www.cvs.com
1-800-shop-CVS
Package Label.Principal Display Panel
Kid'sANTICAVITY FLUORIDE RINSEALCOHOL FREE•Helps prevent cavitiesBubble Gum FlavorIMPORTANT: Read directions for proper use.18 FL OZ (532mL)
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