{"active_ingredient":["Active i ngredient Sodium fluoride 0.02% (0.009% w/v fluoride ion)"],"dosage_and_administration":["Directions a dults and children 6 years of age and older: use twice a day after brushing your teeth with a toothpaste remove cap pour 10 milliliters into cap (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 c hildren under 6 years of age: consult a dentist or doctor"],"effective_time":"20250723","id":"d930bfa0-e3cb-459a-a6c9-e99ac02ece1d","inactive_ingredient":["Inactive ingredients water, sorbitol, poloxamer 407, propylene glycol, sodium phosphate, polysorbate 20, sodium saccharin, sucralose, disodium phosphate, cetylpyridinium chloride, calcium disodium EDTA, sodium benzoate, potassium sorbate, flavor, yellow 5, green 3 (309-165)"],"indications_and_usage":["Use aids in the prevention of dental cavities"],"keep_out_of_reach_of_children":["Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M021"],"brand_name":["ACT Restoring Anticavity Fluoride Mint Burst"],"generic_name":["SODIUM FLUORIDE"],"is_original_packager":[true],"manufacturer_name":["Chattem, Inc."],"package_ndc":["41167-0978-3","41167-0978-6","41167-0978-1"],"product_ndc":["41167-0978"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["313029","1044540"],"spl_id":["d930bfa0-e3cb-459a-a6c9-e99ac02ece1d"],"spl_set_id":["0c7ede82-3b28-40ae-8dfd-cec58825f938"],"substance_name":["SODIUM FLUORIDE"],"unii":["8ZYQ1474W7"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL #1 DENTIST RECOMMENDED BRAND FOR STRENGTHENING ENAMEL ACT RESTORING ANTICAVITY FLUORIDE MOUTHWASH MINT BURST 33.8 oz (1 L) #1 DENTIST RECOMMENDED BRAND FOR STRENGTHENING ENAMEL ACT RESTORING ANTICAVITY FLUORIDE MOUTHWASH MINT BURST 33.8 oz (1 L)"],"purpose":["Purpose Anticavity"],"set_id":"0c7ede82-3b28-40ae-8dfd-cec58825f938","spl_product_data_elements":["ACT Restoring Anticavity Fluoride Mint Burst Sodium fluoride SODIUM FLUORIDE FLUORIDE ION WATER SORBITOL POLOXAMER 407 PROPYLENE GLYCOL SODIUM PHOSPHATE POLYSORBATE 20 SACCHARIN SODIUM SUCRALOSE SODIUM PHOSPHATE, DIBASIC, ANHYDROUS CETYLPYRIDINIUM CHLORIDE EDETATE CALCIUM DISODIUM ANHYDROUS SODIUM BENZOATE POTASSIUM SORBATE FD&C YELLOW NO. 5 FD&C GREEN NO. 3"],"spl_unclassified_section":["ACT ® Restoring ™ Mint Burst Anticavity Fluoride Rinse Drug Facts","Other information contains FD&C yellow no. 5 (tartrazine) as a color additive do not use if safety seal is broken or missing"],"version":"8","warnings":["W arnings Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away."]}