{"active_ingredient":["ACTIVE INGREDIENT Sodium fluoride 0.05% (0.02% w/v fluoride ion)"],"dosage_and_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 out and vigorously swish 10 ml (2 tsp) 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."],"effective_time":"20251223","id":"42ecdcc7-82b3-49f6-bff8-0b38c247433e","inactive_ingredient":["INACTIVE INGREDIENTS: water, stabilized chlorine dioxide, trisodium phosphate, citric acid, peppermint flavor, sucralose"],"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":["CloSYS Fluoride Rinse"],"generic_name":["SODIUM FLUORIDE"],"is_original_packager":[true],"manufacturer_name":["Rowpar Pharmaceuticals, Inc."],"package_ndc":["58578-1234-1","58578-1234-2"],"product_ndc":["58578-1234"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["240698"],"spl_id":["42ecdcc7-82b3-49f6-bff8-0b38c247433e"],"spl_set_id":["1a994f24-99ee-4b27-aab0-e816931a22c8"],"substance_name":["SODIUM FLUORIDE"],"unii":["8ZYQ1474W7"],"upc":["0647692627018","0647692227010"]},"other_safety_information":["OTHER INFORMATION: Do not use if safety seal is broken or missing"],"package_label_principal_display_panel":["Packaging 473ml Inner Label 473 mL Carton 100 ml Label"],"purpose":["PURPOSE Anticavity"],"questions":["Questions or comments? Call 1-800-643-3337"],"set_id":"1a994f24-99ee-4b27-aab0-e816931a22c8","spl_product_data_elements":["CloSYS Fluoride Rinse Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION WATER CHLORINE DIOXIDE SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE ANHYDROUS CITRIC ACID PEPPERMINT SUCRALOSE 473 mL Bottle Label Carton Label 100 mL Bottle Label"],"spl_unclassified_section":["Drug Facts",""],"version":"8","warnings":["WARNING:"]}