{"active_ingredient":["Active ingredient 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. • pour 10 milliliters into cap (10 mL mark on inside of cap); do not fill above the 10 mL mark. • vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out. • do not swallow the rinse. • do not drink from the bottle. • do not rinse mouth with water. • 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":"20241028","id":"0a03a9b2-cbbd-4b73-91db-aea9d3a32264","inactive_ingredient":["Inactive ingredients (Clean Mint) water, sorbitol, sodium benzoate, poloxamer 407, benzyl alcohol, polysorbate 20, flavor, propylene glycol, sodium saccharin, disodium EDTA, disodium phosphate, monosodium phosphate, calcium disodium EDTA, cetylpyridinium chloride, potassium sorbate","Inactive ingredients (Extra Fresh) water, sorbitol, sodium benzoate, poloxamer 407, benzyl alcohol, polysorbate 20, flavor, propylene glycol, sodium saccharin, disodium EDTA, disodium phosphate, monosodium phosphate, calcium disodium EDTA, cetylpyridinium chloride, potassium sorbate, FD&C blue no. 1"],"indications_and_usage":["Uses • aids in the prevention of dental cavities. • the combined daily use of a fluoride preventive treatment rinse and a fluoride toothpaste can help reduce the incidence 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":["M022"],"brand_name":["SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint","SENSODYNE PRONAMEL Intensive Enamel Repair Extra Fresh"],"generic_name":["SODIUM FLUORIDE"],"is_original_packager":[true],"manufacturer_name":["Haleon US Holdings LLC"],"package_ndc":["0135-0449-01","0135-0451-01"],"product_ndc":["0135-0449","0135-0451"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["240698"],"spl_id":["0a03a9b2-cbbd-4b73-91db-aea9d3a32264"],"spl_set_id":["817c0dad-d109-428e-adb5-3354604acc94"],"substance_name":["SODIUM FLUORIDE"],"unii":["8ZYQ1474W7"]},"package_label_principal_display_panel":["Principal Display Panel (Clean Mint) New SENSODYNE PRONAMEL ANTICAVITY FLUORIDE MOUTHWASH INTENSIVE ENAMEL REPAIR CLEAN MINT Cavity Protection Alcohol Free** Helps actively repair weakened enamel* IMPORTANT: Read directions for proper use 16.9 FL OZ (500 mL) Front: 204828 Back: 204832 Sensodyne Pro Inten Enamel Repair Clean Mint 500 mL","Principal Display Panel (Extra Fresh) New SENSODYNE PRONAMEL ANTICAVITY FLUORIDE MOUTHWASH INTENSIVE ENAMEL REPAIR EXTRA FRESH Cavity Protection Alcohol Free** Helps actively repair weakened enamel* IMPORTANT: Read directions for proper use 16.9 FL OZ (500 mL) Front: 204830 Back: 204831 Sensodyne Pro Inten Enamel Repair Extra Fresh 500 mL"],"purpose":["Purpose Anticavity"],"questions":["Questions or comments? 1-866-844-2797"],"set_id":"817c0dad-d109-428e-adb5-3354604acc94","spl_product_data_elements":["SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint sodium fluoride SODIUM FLUORIDE FLUORIDE ION WATER SORBITOL SODIUM BENZOATE POLOXAMER 407 BENZYL ALCOHOL POLYSORBATE 20 PROPYLENE GLYCOL SACCHARIN SODIUM EDETATE DISODIUM SODIUM PHOSPHATE, DIBASIC, ANHYDROUS SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM EDETATE CALCIUM DISODIUM CETYLPYRIDINIUM CHLORIDE POTASSIUM SORBATE SENSODYNE PRONAMEL Intensive Enamel Repair Extra Fresh sodium fluoride SODIUM FLUORIDE FLUORIDE ION WATER SORBITOL SODIUM BENZOATE POLOXAMER 407 BENZYL ALCOHOL POLYSORBATE 20 PROPYLENE GLYCOL SACCHARIN SODIUM EDETATE DISODIUM SODIUM PHOSPHATE, DIBASIC, ANHYDROUS SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM EDETATE CALCIUM DISODIUM CETYLPYRIDINIUM CHLORIDE POTASSIUM SORBATE FD&C BLUE NO. 1"],"spl_unclassified_section":["Other information • do not store above 25°C (77°F)","Other Information Re-mineralizing action for strong and protected teeth* ✓ Alcohol Free** ✓ SLS Free ✓ Paraben Free ✓ Dye Free ALWAYS FOLLOW THE LABEL Do not use if printed safety seal around cap is broken or missing. *when used as directed with a fluoride toothpaste **contains no ethanol Distributed by: Haleon, Warren, NJ 07059 Trademarks are owned or licensed to the Haleon group of companies. ©2023 Haleon group of companies or its licensor. Made in Taiwan"],"version":"3","warnings":["Warning 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."]}