Otc - Active Ingredient
Active ingredientsSodium fluoride 0.05% (0.02% w/v fluoride ion)
Anticavity Fluoride Rinse
FDA Label NDC 36800-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Anticavity Fluoride Rinse (NDC 36800-004). 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, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
PurposeAnticavity rinse
Indications & Usage
Use aids in the prevention of dental cavities
Warnings
Warning
Otc - Keep Out Of Reach Of Children
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Dosage & Administration
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 milliters (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 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)• 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
Storage And Handling
Other information • store at room temperature
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
Other
This product is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Fluoride rinse.
Adverse Reactions
Distributed by: TOPCO ASSOCIATES LLC7711 GROSS POINT ROAD, SKOKIE, IL 60077QUESTIONS? 1-888-423-0139
Package Label.Principal Display Panel
Children'sAlcohol FreeANTIVACITYFLUORIDE RINSE• Strong cavity protection• Helps strengthen teeth• Helps prevent cavities• Freshens breathCOMPARE TO ACT active ingredientIMPORTANT: READDIRECTIONS FOR PROPER USESEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION18 FL OZ (532 mL)
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