{"active_ingredient":["OTC - ACTIVE INGREDIENT Stannous Fluoride 0.63% w/w (0.19% w/v fluoride ion)"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Directions: Dilute As Directed Adults & Children 6 Years and Older Rinse each day after brushing and flossing, or more often if recommended by dentist based on diagnosis. Into mixing vial put 1/8 oz. (2 pump strokes) of concentrated ProDenRx Rinse. Add water to 1 oz line, tightly snap-on cap and shake well. Vigorously swish between teeth 1/2 of mixture for one minute and then spit out. Repeat procedure with remaining mixture. Do not swallow. Do not rinse mouth, eat or drink for 30 minutes. Rinse mixing vial with water after use. Children 6 to 12 Instruct and supervise in good rinsing habits (to minimize swallowing). Children Under 6 Consult a dentist or doctor. For Home Irrigation: Prepare 1 oz of ProDenRex Rinse as described above. Pour into irrigator reservoir, add 4 oz of water and mix thoroughly. Use irrigator as directed. Rinse irrigator with water after use. Other information: This product may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist."],"dosage_and_administration_table":["<table frame=\"void\" width=\"648\"> <tbody> <tr> <td styleCode=\"Botrule Lrule Rrule Toprule\" align=\"left\" valign=\"top\" rowspan=\"7\">Adults &amp; Children 6 Years and Older </td> <td styleCode=\"Lrule Rrule Toprule\" align=\"left\" valign=\"top\"> <list listType=\"unordered\" styleCode=\"Disc\"> <item>Rinse each day after brushing and flossing, or more often if recommended by dentist based on diagnosis.</item> </list> </td> </tr> <tr> <td styleCode=\"Lrule Rrule\" align=\"left\" valign=\"top\"> <list listType=\"unordered\" styleCode=\"Disc\"> <item>Into mixing vial put 1/8 oz. (2 pump strokes) of concentrated ProDenRx Rinse.</item> </list> </td> </tr> <tr> <td styleCode=\"Lrule Rrule\" align=\"left\" valign=\"top\"> <list listType=\"unordered\" styleCode=\"Disc\"> <item>Add water to 1 oz line, tightly snap-on cap and shake well.</item> </list> </td> </tr> <tr> <td styleCode=\"Lrule Rrule\" align=\"left\" valign=\"top\"> <list listType=\"unordered\" styleCode=\"Disc\"> <item>Vigorously swish between teeth 1/2 of mixture for one minute and then spit out.</item> </list> </td> </tr> <tr> <td styleCode=\"Lrule Rrule\" align=\"left\" valign=\"top\"> <list listType=\"unordered\" styleCode=\"Disc\"> <item>Repeat procedure with remaining mixture.</item> </list> </td> </tr> <tr> <td styleCode=\"Lrule Rrule\" align=\"left\" valign=\"top\"> <list listType=\"unordered\" styleCode=\"Disc\"> <item>Do not swallow. Do not rinse mouth, eat or drink for 30 minutes.</item> </list> </td> </tr> <tr> <td styleCode=\"Botrule Lrule Rrule\" align=\"left\" valign=\"top\"> <list listType=\"unordered\" styleCode=\"Disc\"> <item>Rinse mixing vial with water after use.</item> </list> </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\"> <list listType=\"unordered\" styleCode=\"Disc\"> <item>Instruct and supervise in good rinsing habits (to minimize swallowing).<content styleCode=\"bold\"/> </item> </list> </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\"> <list listType=\"unordered\" styleCode=\"Disc\"> <item>Consult a dentist or doctor.</item> </list> </td> </tr> </tbody> </table>"],"effective_time":"20140103","id":"809e5391-5dfa-4dd2-86a9-1561bff734e5","inactive_ingredient":["INACTIVE INGREDIENT Contains one or more of these ingredients: flavor, glycerin Made for and Distributed in US by: Zila Therapeutics, Inc. P.O. Box 3889, Batesville, AR 72503 1-800-228-5595 Reorder Number 2106CID Rev. 1 1008"],"indications_and_usage":["INDICATIONS AND USAGE Approved Uses Control of perio infection Relief of dentin sensitivity Aids in prevention of dental caries (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 809e5391-figure-01 809e5391-figure-02"],"purpose":["OTC - PURPOSE Bacterial inhibition Tooth sensitivity relief Anticavity"],"set_id":"aa3d5625-ff2c-49b2-8d15-fca554d1c19a","spl_product_data_elements":["Pro-Den Rx Stannous Fluoride STANNOUS FLUORIDE FLUORIDE ION GLYCERIN"],"spl_unclassified_section":["Drug Facts"],"version":"2","warnings":["WARNINGS If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away. DO NOT use before mixing with water. Use as directed by a dental professional. This is a fluoride treatment rinse, not a mouthwash. Read directions carefully before using."]}