{"active_ingredient":["Active ingredient Stannous Fluoride 0.63% Rinse Concentrate"],"dosage_and_administration":["Directions Adults and children 6 years of age and older: Do not use before mixing with water Use once a day after brushing your teeth with a toothpaste Separate provided graduated cup from the mixing cap Fill graduated cup to 1/8oz. fill line with Fluoridex Daily Renewal Oral Rinse Concentrate Add warm water to 1 oz. fill line Place the mixing cap onto the filled cap until it snaps closed Shake thoroughly then remove mixing cap Use immediately after preparing the rinse Vigorously swish with half of the prepared solution between your teeth for 1 minute and then spit out Do not swallow the rinse Repeat the procedure with the remaining half of the prepared solution Do not eat or drink for 30 minutes after rinising 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":"20231120","id":"0a96438c-733f-8bce-e063-6394a90a0ce7","inactive_ingredient":["Inactive Ingredients Glycerin, Hydrogenated Starch Hydrolysate, Flavor"],"indications_and_usage":["Use Aids in the prevention of dental cavities"],"keep_out_of_reach_of_children":["Warnings Keep out of reach of children under 6 years of age. 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":["Fluoridex"],"generic_name":["STANNOUS FLUORIDE RINSE"],"is_original_packager":[true],"manufacturer_name":["DEN-MAT HOLDINGS, LLC"],"package_ndc":["59883-004-01"],"product_ndc":["59883-004"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"spl_id":["0a96438c-733f-8bce-e063-6394a90a0ce7"],"spl_set_id":["5e81f073-c0ca-aa38-e053-2a91aa0ab37b"],"substance_name":["STANNOUS FLUORIDE"],"unii":["3FTR44B32Q"]},"other_safety_information":["Other Information This product may produce surface staining of the teeth Adequatetoothbrushing may prevent these stains which are harmful or permanent and may be removed by your dentist Store at controlled room temperature 15º - 30ºC (59º - 86º F) See package insert for additional information For your protection, do not use if tamper seal on box is broken or missing"],"package_label_principal_display_panel":["NDC 59883-004-01 FLUORIDEX DAILY RENEWAL Prescription-Strength Dental Decay Prevention Oral Rinse Concentrate CLEAN MINT 0.63% Stannous Fluoride 8.4 fl. oz. (248 ml) Rx Only Fluoridex_Rinse_image.jpg"],"purpose":["Purpose Anticavity"],"questions":["Questions or comments? Call: 1-800-752-2564"],"set_id":"5e81f073-c0ca-aa38-e053-2a91aa0ab37b","spl_product_data_elements":["Fluoridex Stannous Fluoride Rinse STANNOUS FLUORIDE FLUORIDE ION GLYCERIN HYDROGENATED STARCH HYDROLYSATE"],"version":"3","warnings":["Do not swallow the rinse"]}