{"active_ingredient":["OTC - ACTIVE INGREDIENT Stannous fluoride 0.4% w/w (0.13% w/v fluoride ion) Contains 0.4% Stannous Fluoride in a Stable, Water Free Gel"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION DIRECTIONS: Adults and Children 6 Years and Older This is a fluoride preventive treatment gel, not a toothpaste. Use once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not eat or drink for 30 minutes after brushing. Children 6 to 12 Instruct and supervise brushing and rinsing (to minimize swallowing) until good brushing habits are established. Children Under 6 Ask a dentist or doctor. OTHER INFORMATION: This product may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dental professional."],"dosage_and_administration_table":["<table frame=\"void\" width=\"744\"> <tbody> <tr> <td styleCode=\"Botrule Lrule Rrule Toprule\" align=\"left\" valign=\"top\">Adults and Children 6 Years and Older  </td> <td styleCode=\"Botrule Lrule Rrule Toprule\" align=\"left\" valign=\"top\">This is a fluoride preventive treatment gel, not a toothpaste. Use once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not eat or drink for 30 minutes after brushing.</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 brushing and rinsing (to minimize swallowing) until good brushing habits are established.</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\">Ask a dentist or doctor.</td> </tr> </tbody> </table>"],"effective_time":"20140116","id":"161ffc6c-b061-443f-b7c0-edc87ec8e86f","inactive_ingredient":["INACTIVE INGREDIENT Natural flavor, glycerin and hydroxyethyl cellulose 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 USES Aids in prevention of dental caries (cavities). The combined daily use of a fluoride preventive treatment gel 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 161ffc6c-figure-01"],"purpose":["OTC - PURPOSE Anticavity"],"set_id":"466fe5be-4c4f-4b91-81a7-93d3fbe09513","spl_product_data_elements":["Stannous Fluoride Stannous Fluoride STANNOUS FLUORIDE FLUORIDE ION GLYCERIN HYDROXYETHYL CELLULOSE (140 CPS AT 5%)"],"spl_unclassified_section":["DRUG FACTS"],"version":"5","warnings":["WARNINGS If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Use only under guidance or supervision of a dentist."]}