{"active_ingredient":["Active ingredient Sodium Fluoride 0.243% (0.14 w/v fluoride ion)"],"dosage_and_administration":["Directions Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or use as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habtis ( to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor."],"effective_time":"20260115","id":"4879acb9-cfa0-ded2-e063-6294a90ac5a7","inactive_ingredient":["Inactive ingredients Water Sorbitol Glycerin Hydrated Silica Xylitol Sodium Phosphate Xanthan Gum Sodium Lauroyl Sarcosinate Tetrapotassium Pyrophosphate 1,2-Hexanediol Cellulose Gum Sucralose Lauryl Glucoside Methyl Diisopropyl Propionamide Sodium Gluconate Zinc Lactate D&C Red No. 33"],"indications_and_usage":["Use Aids in the prevention of dental cavities"],"keep_out_of_reach_of_children":["Keep out of reach of children under 6 years of age If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M021"],"brand_name":["HISMILE"],"generic_name":["SODIUM FLUORIDE"],"is_original_packager":[true],"manufacturer_name":["HISMILE PTY LTD"],"package_ndc":["83013-323-06"],"product_ndc":["83013-323"],"product_type":["HUMAN OTC DRUG"],"route":["DENTAL"],"rxcui":["416783"],"spl_id":["4879acb9-cfa0-ded2-e063-6294a90ac5a7"],"spl_set_id":["1d447939-fbf6-42f6-e063-6294a90af6d9"],"substance_name":["SODIUM FLUORIDE"],"unii":["8ZYQ1474W7"]},"package_label_principal_display_panel":["label label label"],"purpose":["Purpose Anticavity"],"set_id":"1d447939-fbf6-42f6-e063-6294a90af6d9","spl_product_data_elements":["HISMILE Sodium Fluoride XYLITOL HYDRATED SILICA SODIUM LAUROYL SARCOSINATE GLYCERIN 1,2-HEXANEDIOL CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM WATER SODIUM FLUORIDE FLUORIDE ION SORBITOL SODIUM PHOSPHATE XANTHAN GUM POTASSIUM PYROPHOSPHATE SUCRALOSE LAURYL GLUCOSIDE SODIUM GLUCONATE ZINC LACTATE METHYL DIISOPROPYL PROPIONAMIDE D&C RED NO. 33"],"version":"3","warnings":["Warnings Warnings When using this product Do not swallow Do not use in eye area Keep out of reach of children under 6 years of age If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product Do not swallow Do not use in eye area"]}