{"active_ingredient":["Active ingredient Sodium fluoride 0.254% (0.15% w/v fluoride ion)"],"dosage_and_administration":["Directions • adults and children 2 years of age and older: o brush teeth thoroughly, preferably after each meal or at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing. o to minimize swallowing for children under 6 years of age, use a pea-sized amount and rinsing until good habits are established. • children under 2 years of age: Consult a dentist or doctor."],"effective_time":"20250703","id":"395866d4-ad69-4f60-8c4c-1c910aba1c38","inactive_ingredient":["Inactive ingredients water, sorbitol, hydrated silica, glycerin, PEG-8, cocamidopropyl betaine, xanthan gum, flavor, sodium saccharin, sodium hydroxide, red 30"],"indications_and_usage":["Use • aids in the prevention of dental cavities."],"keep_out_of_reach_of_children":["Keep out of the 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":["M022"],"brand_name":["Sensodyne Pronamel Kids Berry Twist"],"generic_name":["SODIUM FLUORIDE"],"is_original_packager":[true],"manufacturer_name":["Haleon US Holdings LLC"],"package_ndc":["0135-0809-01","0135-0809-02","0135-0809-03"],"product_ndc":["0135-0809"],"product_type":["HUMAN OTC DRUG"],"route":["DENTAL"],"spl_id":["395866d4-ad69-4f60-8c4c-1c910aba1c38"],"spl_set_id":["69c07c36-b5e0-420b-ab29-7d1091386322"],"substance_name":["SODIUM FLUORIDE"],"unii":["8ZYQ1474W7"]},"package_label_principal_display_panel":["Principal Display Panel FLUORIDE ANTICAVITY TOOTHPASTE new HALEON Sensodyne PRONAMEL KIDS Berry Twist 24hr Cavity Protection* 2x Stronger Enamel Defense** NET WT 4.0 OZ (113 g) 62000000212335 Front Label Sensodyne Pronamel Kids Berry Twist 4.0 oz (113 g).jpg"],"purpose":["Purpose Anticavity"],"questions":["Questions or comments? 1-866-844-2797 ALWAYS FOLLOW THE LABEL"],"set_id":"69c07c36-b5e0-420b-ab29-7d1091386322","spl_product_data_elements":["Sensodyne Pronamel Kids Berry Twist sodium fluoride SODIUM FLUORIDE FLUORIDE ION WATER SORBITOL HYDRATED SILICA GLYCERIN POLYETHYLENE GLYCOL 400 COCAMIDOPROPYL BETAINE XANTHAN GUM SACCHARIN SODIUM SODIUM HYDROXIDE D&C RED NO. 30"],"spl_unclassified_section":["Other information • do not store above 25°C (77°F)"],"version":"2","warnings":["Warnings Keep out of the 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."]}