{"active_ingredient":["OTC - ACTIVE INGREDIENT Sodium Fluoride 0.044% w/w (0.02% w/v fluoride ion)"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Directions: This is a fluoride treatment rinse, not a mouthwash. Read directions carefully before using. Adults and Children 6 yrs and older Use once a day after brushing your teeth with a toothpaste. Vigorously swish 10 ml of rinse between your teeth for one minute, then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing. Children 6 to 12 Instruct and supervise in good rinsing (to minimize swallowing). Children Under 6 Consult a dentist or doctor."],"dosage_and_administration_table":["<table frame=\"void\" width=\"648\"> <tbody> <tr> <td styleCode=\"Botrule Lrule Rrule Toprule\" align=\"left\" valign=\"top\">Adults and Children 6 yrs and older  </td> <td styleCode=\"Botrule Lrule Rrule Toprule\" align=\"left\" valign=\"top\">Use once a day after brushing your teeth with a toothpaste. Vigorously swish 10 ml of rinse between your teeth for one minute, then spit out. <content styleCode=\"bold\">Do not swallow the rinse. </content>Do not eat or drink for 30 minutes after rinsing.</td> </tr> <tr> <td styleCode=\"Botrule Lrule Rrule Toprule\" align=\"left\" valign=\"top\">Children 6 to 12  </td> <td styleCode=\"Botrule Lrule Rrule Toprule\" align=\"left\" valign=\"top\">Instruct and supervise in good rinsing (to minimize swallowing). </td> </tr> <tr> <td styleCode=\"Botrule Lrule Rrule Toprule\" align=\"left\" valign=\"top\">Children Under 6  </td> <td styleCode=\"Botrule Lrule Rrule Toprule\" align=\"left\" valign=\"top\">Consult a dentist or doctor.</td> </tr> </tbody> </table>"],"effective_time":"20131216","id":"2e68304f-e3d3-4917-9778-9f66dadcac7b","inactive_ingredient":["INACTIVE INGREDIENT Inactive Ingredients: Distilled water, monosodium phosphate, sodium benzoate, sodium saccharin, artificial color, artificial flavor. Made for and Distributed in US by: Zila Therapeutics, Inc., P.O. Box 3889, Batesville, AR 72503 1-800-228-5595"],"indications_and_usage":["INDICATIONS AND USAGE Approved Uses Aids in prevention of dental caries (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":["OTC - KEEP OUT OF REACH OF CHILDREN Please keep out of reach of children."],"openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 2e68304f-figure-01"],"purpose":["OTC - PURPOSE Anticavity"],"set_id":"510028eb-2d76-44b5-a65c-642cbca813d0","spl_product_data_elements":["Pro-Den Rx Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION SODIUM BENZOATE SACCHARIN SODIUM WATER SODIUM PHOSPHATE, MONOBASIC ANHYDROUS"],"spl_unclassified_section":["Drug Facts"],"version":"6","warnings":["WARNINGS If more than used for rinsing is accidentally swallowed get medical help or contact a Poison Control Center right away. Use only under guidance or supervision of a dentist or doctor."]}