{"active_ingredient":["Active i ngredient Sodium fluoride 0.02% (0.009% w/v fluoride ion)"],"dosage_and_administration":["Directions a dults and children 12 years of age and older: ■ use twice a day after brushing your teeth with a toothpaste ■ vigorously swish 10 milliliters (2 teaspoonfuls) 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 ■ supervise children as necessary until capable of using without supervision c hildren under 12 years of age: consult a dentist or doctor"],"effective_time":"20260112","id":"e0e0a4a0-368c-4b6c-94bb-0988f3d8cc58","inactive_ingredient":["Inactive ingredients water, glycerin, xylitol, hydrogen peroxide, poloxamer 407, propylene glycol, pentylene glycol, flavors, sodium benzoate, sodium phosphate, disodium phosphate, 4-t-butylcyclohexanol, menthol, sucralose, sodium saccharin, calcium disodium EDTA"],"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 Whitening Anticavity Gentle Mint"],"generic_name":["SODIUM FLUORIDE 0.02 (0.009 W/V FLUORIDE ION)"],"is_original_packager":[true],"manufacturer_name":["Chattem, Inc."],"package_ndc":["41167-0983-2"],"product_ndc":["41167-0983"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["313029","1044540"],"spl_id":["e0e0a4a0-368c-4b6c-94bb-0988f3d8cc58"],"spl_set_id":["cd45a0b8-9ab3-4aed-8214-a6dcc4cdaf49"],"substance_name":["SODIUM FLUORIDE"],"unii":["8ZYQ1474W7"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL ACT WHITENING ANTICAVITY FLUORIDE MOUTHWASH GENTLE MINT 16.9 fl oz (500 mL) PRINCIPAL DISPLAY PANEL ACT WHITENING ANTICAVITY FLUORIDE MOUTHWASH GENTLE MINT 16.9 fl oz (500 mL) PRINCIPAL DISPLAY PANEL ACT WHITENING ANTICAVITY FLUORIDE MOUTHWASH GENTLE MINT 16.9 fl oz (500 mL)"],"purpose":["Purpose Anticavity"],"set_id":"cd45a0b8-9ab3-4aed-8214-a6dcc4cdaf49","spl_product_data_elements":["ACT Whitening Anticavity Gentle Mint sodium fluoride 0.02 (0.009 w/v fluoride ion) SODIUM FLUORIDE FLUORIDE ION WATER GLYCERIN XYLITOL HYDROGEN PEROXIDE POLOXAMER 407 PROPYLENE GLYCOL PENTYLENE GLYCOL SODIUM BENZOATE SODIUM PHOSPHATE SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 4-TERT-BUTYLCYCLOHEXANOL MENTHOL SUCRALOSE SACCHARIN SODIUM EDETATE CALCIUM DISODIUM ANHYDROUS"],"spl_unclassified_section":["ACT Whitening Anticavity Gentle Mint Drug Facts","Other information ■ do not use if safety seal is broken or missing"],"stop_use":["Stop use and ask a dentist if oral irritation or tooth sensitivity occurs"],"version":"5","warnings":["Warnings Stop use and ask a dentist if oral irritation or tooth sensitivity occurs 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."]}