{"description":["Description A water soluble topical fluoride rinse to assist in preventing dental caries. For professional use only."],"dosage_and_administration":["Directions Directions: Read directions carefully before using. The following treatment method provides a high initial protection level on tooth surfaces. Adults and children 6 years of age and older: use as indicated below, inconjunction with oral hygiene program. 1.For combined Stannous fluoride and A.P.F treatment, dispense 7 mL of Acclean Stannous fluoride concentrate (part A) and 7 mL of Acclean A.P.F. (part B) into a cup by depressing each plunger once. 2.Add 21 mL of water and mix well. This provides a 0.33% Stannous solution with 0.25% acidulated phosphate fluoride. 3.Instruct patient to rinse mouth with 1/2 of the solution for 60 seconds. 4.Expectorate and repeat the procedure with the remaining solution. 5.Use only freshly prepared solution for each patient. 6.Instruct patient not to eat or drink for 30 minutes after use."],"effective_time":"20201209","id":"b60dbf58-d58b-7379-e053-2995a90af5e2","openfda":{},"package_label_principal_display_panel":["Main Panel 104-9034 Full Label"],"set_id":"49c7e202-2f5d-4747-e054-00144ff88e88","spl_product_data_elements":["Acclean Dual Fluoride Rinse Part B 1.24% Mint Fluoride SODIUM FLUORIDE FLUORIDE ION"],"spl_unclassified_section":["Distributed by (in US only): Henry Schein Inc., 135 Duryea Road, Melville, NY 11747 USA Made in USA Rev.02"],"storage_and_handling":["Storage Warning: Store at room temperature. Do not expose to excessive heat over 40°C, 104°F ."],"version":"3","warnings_and_cautions":["Warning Children under 12 years of age should be supervised during treatment. Consult a dentist or doctor before using on children under 6 years of age. Keep out of reach of children under age 6. Do not swallow. Rx Only"]}