{"active_ingredient":["Active ingredient Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)"],"dosage_and_administration":["Directions adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 2 years ask a dentist or physician"],"dosage_and_administration_table":["<table width=\"75%\"><col width=\"30%\" align=\"left\" valign=\"top\"/><col width=\"70%\" align=\"left\" valign=\"top\"/><tbody><tr styleCode=\"Toprule\"><td styleCode=\"Botrule\">adults and children 2 years of age and older</td><td styleCode=\"Lrule Botrule\">brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician</td></tr><tr styleCode=\"Botrule\"><td>children 2 to 6 years</td><td styleCode=\"Lrule\">use only a pea sized amount and supervise child&apos;s brushing and rinsing (to minimize swallowing)</td></tr><tr styleCode=\"Botrule\"><td>children under 2 years</td><td styleCode=\"Lrule\">ask a dentist or physician</td></tr></tbody></table>"],"effective_time":"20251208","id":"457da70c-ba2e-468b-e063-6394a90a276a","inactive_ingredient":["Inactive ingredients dicalcium phosphate dihydrate, water, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, sodium saccharin"],"indications_and_usage":["Use helps protect against cavities"],"keep_out_of_reach_of_children":["If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Keep out of the reach of children under 6 years of age."],"openfda":{"application_number":["M021"],"brand_name":["First Class Kit"],"generic_name":["SODIUM MONOFLUOROPHOSPHATE"],"is_original_packager":[true],"manufacturer_name":["American Airlines, Inc."],"package_ndc":["58701-001-10"],"product_ndc":["58701-001"],"product_type":["HUMAN OTC DRUG"],"route":["DENTAL"],"rxcui":["545626"],"spl_id":["457da70c-ba2e-468b-e063-6394a90a276a"],"spl_set_id":["ba717de8-c3a2-41bf-85a1-aa75f9744d30"],"substance_name":["SODIUM MONOFLUOROPHOSPHATE"],"unii":["C810JCZ56Q"]},"package_label_principal_display_panel":["Package Labeling: Colgate Drug Facts3 Label4"],"purpose":["Purpose Anticavity"],"questions":["Questions or comments? Call toll-free 1-800-468-6502"],"set_id":"ba717de8-c3a2-41bf-85a1-aa75f9744d30","spl_product_data_elements":["First Class Kit Sodium Monofluorophosphate CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE WATER SORBITOL SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SODIUM SODIUM PYROPHOSPHATE SACCHARIN SODIUM LIMONENE, (+/-)- SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION"],"version":"10","warnings":["Warnings If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Keep out of the reach of children under 6 years of age."]}