Active Ingredient
Sodium fluoride 0.05% (0.02%w/v fluoride ion)
Anticavity Fluoride Rinse Mouthwash
FDA Label NDC 59779-004
11 label sections · Submitted to the FDA by Cvs Pharmacy, Inc. · 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 active ingredient, purpose, use, warning, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anticavity
Use
aids in the prevention of dental cavities
Warning
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
- 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
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
Disclaimer
*This product is not manufactured or distributed by Chattem, Inc., distributor of Act ® Anticavity Kids Fluoride Rinse.
Adverse Reaction
Distributed by CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
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ADA Accepted
American Dental Association
Helps prevent cavities
Principal Display Panel
Sealed with printed neckband for your protection
CVS™
Children's
ANTICAVITY FLUORIDE RINSE
Sodium Fluoride 0.05%
Anticavity
Bubblegum Flavor
Compare to ACT ® Anticavity Kids Fluoride Rinse*
Helps Prevent Cavities & Strengthen Teeth
Alcohol free
ADA Accepted
American Dental Association ®
IMPORTANT: Read directions for proper use.
18 FL OZ (1.12 PT) 532 mL
Image Description (Mm01)
Image Description (Mm02)
* Please review the disclaimer below.
