{"active_ingredient":["Active ingredient Potassium nitrate 5% Sodium fluoride 0.25% (0.15% w/v fluoride ion)"],"dosage_and_administration":["Directions adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush. brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing. children under 12 years of age: Consult a dentist or doctor."],"effective_time":"20240304","id":"12dd7448-a7e1-9b94-e063-6394a90a6d48","inactive_ingredient":["Inactive ingredients water, sorbitol, hydrated silica, glycerin, PEG-8, sodium lactate, flavor, xanthan gum, cocamidopropyl betaine, sodium methyl cocoyl taurate, titanium dioxide, sodium saccharin, PVM/MA copolymer, sodium hydroxide"],"indications_and_usage":["Uses builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. aids in the prevention of dental cavities."],"keep_out_of_reach_of_children":["Keep out of reach of children. 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 Active Shield Fresh Mint","SENSODYNE PRONAMEL Active Shield Cool Mint"],"generic_name":["POTASSIUM NITRATE AND SODIUM FLUORIDE"],"is_original_packager":[true],"manufacturer_name":["Haleon US Holdings LLC"],"package_ndc":["0135-0700-01","0135-0700-02","0135-0701-01","0135-0701-02","0135-0701-03"],"product_ndc":["0135-0700","0135-0701"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1086243"],"spl_id":["12dd7448-a7e1-9b94-e063-6394a90a6d48"],"spl_set_id":["e8684615-f544-4871-b935-0a0f93639d7d"],"substance_name":["POTASSIUM NITRATE","SODIUM FLUORIDE"],"unii":["8ZYQ1474W7","RU45X2JN0Z"]},"package_label_principal_display_panel":["Principal Display Panel SENSODYNE PRONAMEL ACTIVE SHIELD TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION FRESH MINT Builds Enamel Resistance For Cavity & Erosion Protection NET WT 3.4 OZ (96.4 g) 62000000200006 – Front Carton Sensodyne Pronamel Active Shield FM 3.4oz_Carton","Principal Display Panel SENSODYNE PRONAMEL ACTIVE SHIELD TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION COOL MINT WHITENING Builds Enamel Resistance For Cavity & Erosion Protection NET WT 3.4 OZ (96.4 g) 620000000200004 – Front Carton Sensodyne Pronamel Active Shield CM 3.4oz_Carton"],"purpose":["Purposes Antihypersensitivity Anticavity"],"questions":["Questions or comments? 1-866-844-2797"],"set_id":"e8684615-f544-4871-b935-0a0f93639d7d","spl_product_data_elements":["SENSODYNE PRONAMEL Active Shield Fresh Mint potassium nitrate and sodium fluoride WATER SORBITOL HYDRATED SILICA GLYCERIN POLYETHYLENE GLYCOL 400 SODIUM LACTATE XANTHAN GUM COCAMIDOPROPYL BETAINE SODIUM METHYL COCOYL TAURATE TITANIUM DIOXIDE SACCHARIN SODIUM SODIUM HYDROXIDE POTASSIUM NITRATE NITRATE ION SODIUM FLUORIDE FLUORIDE ION Fresh Mint SENSODYNE PRONAMEL Active Shield Cool Mint potassium nitrate and sodium fluoride WATER SORBITOL HYDRATED SILICA GLYCERIN POLYETHYLENE GLYCOL 400 SODIUM LACTATE XANTHAN GUM COCAMIDOPROPYL BETAINE SODIUM METHYL COCOYL TAURATE TITANIUM DIOXIDE SACCHARIN SODIUM SODIUM HYDROXIDE POTASSIUM NITRATE NITRATE ION SODIUM FLUORIDE FLUORIDE ION Cool Mint"],"spl_unclassified_section":["Additional information (Fresh Mint) SENSODYNE PRONAMEL ACTIVE SHIELD No 1 dentist recommended brand for enamel protection & strengthening. Enamel is your natural defense shield for healthy teeth. Everyday it can be weakened by dietary or sugar acids which make your teeth more at risk to cavities and enamel wear. New Pronamel Active Shield – start building resistance today to help keep your teeth strong and healthy for life.** Acids from foods, drinks or sugars weaken the enamel surface Pronamel has a proven formula that actively reinforces weakened enamel Proven to actively reinforce weakened enamel Developed for defense against cavities and enamel wear by remineralizing your weakened enamel. Pronamel Active Shield helps with: 2X stronger resistance against dietary acids from Day 1* Helps shield the enamel against erosion and cavities Enhanced foaming action# with extra fresh mint to leave the whole mouth feeling clean and fresh *vs your mouth’s natural defenses ** With continued twice daily brushing, a healthy diet and regular dental visits. #vs Pronamel Daily Protection ALWAYS FOLLOW THE LABEL Trademarks owned or licensed by GSK. ©2022 GSK or licensor. Distributed by: GSK Consumer Healthcare, Warren, NJ 07059","Additional information (Cool Mint) S ENSODYNE PRONAMEL ACTIVE SHIELD No 1 dentist recommended brand for enamel protection & strengthening. Enamel is your natural defense shield for healthy teeth. Everyday it can be weakened by dietary or sugar acids which make your teeth more at risk to cavities and enamel wear. New Pronamel Active Shield – start building resistance today to help keep your teeth strong and healthy for life.** Acids from foods, drinks or sugars weaken the enamel surface Pronamel has a proven formula that actively reinforces weakened enamel Proven to actively reinforce weakened enamel Developed for defense against cavities and enamel wear by remineralizing your weakened enamel. Pronamel Active Shield helps with: 2X stronger resistance against dietary acids from Day 1* Helps shield the enamel against erosion and cavities Enhanced foaming action# with extra fresh mint to leave the whole mouth feeling clean and fresh Effectively and gently removes stains for whiter teeth *vs your mouth’s natural defenses ** With continued twice daily brushing, a healthy diet and regular dental visits. #vs Pronamel Daily Protection ALWAYS FOLLOW THE LABEL Trademarks owned or licensed by GSK. ©2022 GSK or licensor. Distributed by: GSK Consumer Healthcare, Warren, NJ 07059"],"stop_use":["Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. pain/sensitivity still persists after 4 weeks of use."],"storage_and_handling":["Other information do not store above 25°C (77°F)"],"version":"4","warnings":["Warnings Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. pain/sensitivity still persists after 4 weeks of use. Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away."]}