{"active_ingredient":["Active i ngredient 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 ■ hold bottle upright and squeeze. Fill to FILL LINE. ■ pour out. Only the correct 10 milliliters dose will pour out. ■ 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 children under 6 years of age: consult a dentist or doctor"],"effective_time":"20260112","id":"99084e0e-deca-420d-aa5d-e0347b8296c5","inactive_ingredient":["Inactive ingredients benzyl alcohol, blue 1, calcium disodium EDTA, cetylpyridinium chloride, disodium phosphate, flavor, poloxamer 407, polysorbate 20, potassium sorbate, propylene glycol, red 33, sodium benzoate, sodium phosphate, sorbitol, sucralose, water"],"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 Anticavity Fluoride Kids Groovy Grape"],"generic_name":["SODIUM FLUORIDE"],"is_original_packager":[true],"manufacturer_name":["Chattem, Inc."],"package_ndc":["41167-0945-0"],"product_ndc":["41167-0945"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["240698","656809"],"spl_id":["99084e0e-deca-420d-aa5d-e0347b8296c5"],"spl_set_id":["cd167c0b-2086-4204-b0ac-90df404bd4bb"],"substance_name":["SODIUM FLUORIDE"],"unii":["8ZYQ1474W7"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL ACT Kids ANTICAVITY FLUORIDE RINSE GROOVY GRAPE 16.9 fl oz (500 mL) ACT Kids ANTICAVITY FLUORIDE RINSE GROOVY GRAPE 16.9 fl oz (500 mL)"],"purpose":["Purpose Anticavity"],"set_id":"cd167c0b-2086-4204-b0ac-90df404bd4bb","spl_product_data_elements":["ACT Anticavity Fluoride Kids Groovy Grape Sodium fluoride SODIUM FLUORIDE FLUORIDE ION SODIUM PHOSPHATE, DIBASIC, ANHYDROUS BENZYL ALCOHOL FD&C BLUE NO. 1 EDETATE CALCIUM DISODIUM ANHYDROUS CETYLPYRIDINIUM CHLORIDE POLOXAMER 407 POLYSORBATE 20 POTASSIUM SORBATE PROPYLENE GLYCOL D&C RED NO. 33 SODIUM BENZOATE SODIUM PHOSPHATE SORBITOL SUCRALOSE WATER"],"spl_unclassified_section":["ACT Anticavity Kids Rinse Groovy Grape 0.05% Drug Facts","Other information ■ do not use if safety seal is broken or missing"],"version":"6","warnings":["Warnings 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."]}