{"active_ingredient":["Active ingredient Sodium fluoride 0.04% (0.02% w/v fluoride ion)"],"dosage_and_administration":["Directions adults and children 6 years of age and older use once a day after brushing your teeth with a toothpaste vigorously swish 10 milliliters (10 mL mark on cap or 2 teaspoonfuls) of rinse between your teeth for 1 minute then spit out do not swallow the rinse do not eat or drink for 30 minutes after rinsing instruct children under 12 years of age in good rinsing habits (to minimize swallowing) supervise children as necessary until capable of using without supervision children under 6 years of age ask a dentist or physician"],"dosage_and_administration_table":["<table width=\"70%\" styleCode=\"Noautorules\"><col width=\"25%\" valign=\"top\" align=\"left\"/><col width=\"75%\" valign=\"top\" align=\"left\"/><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">adults and children 6 years of age and older</td><td><list listType=\"unordered\"><item>use once a day after brushing your teeth with a toothpaste</item><item>vigorously swish 10 milliliters (10 mL mark on cap or 2 teaspoonfuls) of rinse between your teeth for 1 minute then spit out</item><item>do not swallow the rinse</item><item>do not eat or drink for 30 minutes after rinsing</item><item>instruct children under 12 years of age in good rinsing habits (to minimize swallowing)</item><item>supervise children as necessary until capable of using without supervision</item></list></td></tr><tr><td styleCode=\"Rrule\">children under 6 years of age</td><td><list listType=\"unordered\"><item>ask a dentist or physician</item></list></td></tr></tbody></table>"],"effective_time":"20240112","id":"0c0515c6-25cb-46b6-ada6-79f8aeb97a28","inactive_ingredient":["Inactive ingredients water, sorbitol, sodium phosphate, flavor, potassium sorbate, phosphoric acid, polysorbate 20, FD&C blue no. 1, FD&C red no. 40"],"indications_and_usage":["Use aids in the prevention of dental cavities"],"keep_out_of_reach_of_children":["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."],"openfda":{"application_number":["M021"],"brand_name":["Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride"],"generic_name":["SODIUM FLUORIDE"],"is_original_packager":[true],"manufacturer_name":["Colgate Oral Pharmaceuticals, Inc."],"package_ndc":["0126-0034-46"],"product_ndc":["0126-0034"],"product_type":["HUMAN OTC DRUG"],"route":["DENTAL"],"rxcui":["313029","1721964"],"spl_id":["0c0515c6-25cb-46b6-ada6-79f8aeb97a28"],"spl_set_id":["9a976ac8-d966-4d94-93da-45652f2d2481"],"substance_name":["SODIUM FLUORIDE"],"unii":["8ZYQ1474W7"],"upc":["0038341104309"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label ALCOHOL FREE* Colgate ® Phos•Flur ® Ortho Defense ® Anticavity Fluoride Rinse Sodium Fluoride Acidulated Phosphate Solution IDEAL PROTECTION WHILE WEARING BRACES ✓ ORTHODONTIST RECOMMENDED ✓ HELPS STRENGTHEN ENAMEL ✓ HELPS PREVENT CAVITIES GUSHING GRAPE 16.9 FL OZ (1.05 PT) 500 mL IMPORTANT: Read directions for proper use ADA Accepted American Dental Association ® P9910320 Principal Display Panel - 500 mL Bottle Label"],"purpose":["Purpose Anticavity"],"questions":["Questions? 1-800-468-6502"],"set_id":"9a976ac8-d966-4d94-93da-45652f2d2481","spl_product_data_elements":["Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION WATER SORBITOL SODIUM PHOSPHATE POTASSIUM SORBATE PHOSPHORIC ACID POLYSORBATE 20 FD&C BLUE NO. 1 FD&C RED NO. 40"],"spl_unclassified_section":["Drug Facts","Dist. by: COLGATE-PALMOLIVE COMPANY New York, NY 10022"],"storage_and_handling":["Other Information store at controlled room temperature 68 – 77° F (20 – 25°C)"],"version":"8","warnings":["Warnings 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."]}