{"active_ingredient":["OTC - ACTIVE INGREDIENT Sodium Fluoride 0.044% w/w (0.02% w/v fluoride ion)"],"effective_time":"20100816","id":"7f549575-e740-4963-b105-ef4b4f850a2d","openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 7f549575-figure-01"],"purpose":["OTC - PURPOSE Anticavity 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. Warnings Please 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. Use only under guidance or supervision of a dentist or doctor. 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. 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"],"purpose_table":["<table frame=\"void\" width=\"648\"> <tbody> <tr> <td styleCode=\"BotruleLruleRruleToprule\" align=\"left\" valign=\"top\">Adults and Children 6 yrs and older  </td> <td styleCode=\"BotruleLruleRruleToprule\" 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=\"BotruleLruleRruleToprule\" align=\"left\" valign=\"top\">Children 6 to 12  </td> <td styleCode=\"BotruleLruleRruleToprule\" align=\"left\" valign=\"top\">Instruct and supervise in good rinsing (to minimize swallowing). </td> </tr> <tr> <td styleCode=\"BotruleLruleRruleToprule\" align=\"left\" valign=\"top\">Children Under 6  </td> <td styleCode=\"BotruleLruleRruleToprule\" align=\"left\" valign=\"top\">Consult a dentist or doctor.</td> </tr> </tbody> </table>"],"set_id":"7a1a6bfd-728d-4123-8381-dd405e84e753","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":"1"}