{"active_ingredient":["Drug Facts Active ingredient Povidone-iodine, 0.5% (0.05% available iodine)"],"do_not_use":["Do not use this product for more than 7 days unless directed by a dentist or doctor in children under 12 years of age unless directed by a dentist or doctor if you are allergic to povidone-iodine or any other ingredients in this product if you have any thyroid conditions"],"dosage_and_administration":["Directions Use full strength Apply 10 to 20 milliliters of solution to the operative site. Instruct the patient to rinse for 30 seconds and then spit out. Wait 2 minutes, and apply another 10 to 20 milliliters of solution to the operative site. Instruct the patient to rinse again for 30 seconds and then spit out. With a standard syringe and a blunt, angulated needle, irrigate the operative site and the surrounding gingival mucosa for 1 minute with 10 to 20 milliliters of the solution. Instruct the patient to spit out the solution after the irrigation procedure."],"effective_time":"20250108","id":"2b35c722-769f-89b1-e063-6294a90ad717","inactive_ingredient":["Inactive ingredients citric acid, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium hydroxide"],"indications_and_usage":["Uses For preparation of the oral mucosa prior to injection, dental surgery, or tooth extraction"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{},"package_label_principal_display_panel":["Betadine Oral Rinse NDC: 67618-182-08 Betadine Oral Rinse label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away."],"purpose":["Purpose Oral Antiseptic Uses For preparation of the oral mucosa prior to injection, dental surgery, or tooth extraction"],"set_id":"6ee3fcda-15e5-3754-8ea9-39ba03359ad7","spl_product_data_elements":["BETADINE Antiseptic Oral Rinse POVIDONE-IODINE GLYCERIN PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM HYDROXIDE ANHYDROUS CITRIC ACID POVIDONE-IODINE IODINE"],"spl_unclassified_section":["Dist. by: Avrio Health L.P. Stamford, CT 06901-3431 305765-0B"],"stop_use":["Stop use and ask a doctor or dentist if symptoms do not improve in 7 days irritation, pain, or redness persists or worsens swelling, rash, or fever develops"],"storage_and_handling":["Other information store at 25⁰C (77⁰F); excursions permitted between 15⁰-30⁰C (59⁰-86⁰F) may stain clothing or dental work avoid contact with jewelry, especially silver"],"version":"5","warnings":["Warnings Do not use this product for more than 7 days unless directed by a dentist or doctor in children under 12 years of age unless directed by a dentist or doctor if you are allergic to povidone-iodine or any other ingredients in this product if you have any thyroid conditions When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water. If irritation persists, consult a doctor do not swallow do not use with hydrogen peroxide Stop use and ask a doctor or dentist if symptoms do not improve in 7 days irritation, pain, or redness persists or worsens swelling, rash, or fever develops"],"when_using":["When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water. If irritation persists, consult a doctor do not swallow do not use with hydrogen peroxide"]}