{"active_ingredient":["Active Ingredient Sodium fluoride (0.24%) (0.15% w/v fluoride ion)"],"dosage_and_administration":["Directions twist off cap and remove foil seal do not swallow supervise children as necessary until capable of using without supervision adults and children 2 years and older brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician children under 6 years instruct in good brushing and rinsing habits (to minimize swallowing) children under 2 years ask a dentist or physician"],"dosage_and_administration_table":["<table width=\"65%\" styleCode=\"Noautorules\"><col width=\"30%\" align=\"left\" valign=\"top\"/><col width=\"70%\" align=\"left\" valign=\"top\"/><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">adults and children 2 years and older</td><td>brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">children under 6 years</td><td>instruct in good brushing and rinsing habits (to minimize swallowing)</td></tr><tr><td styleCode=\"Rrule\">children under 2 years</td><td>ask a dentist or physician</td></tr></tbody></table>"],"effective_time":"20240223","id":"703c32bc-8273-4875-83fe-bd7c29583f95","inactive_ingredient":["Inactive ingredients Sorbitol (corn), Water, Hydrated Silica (mineral), Glycerin (vegetable), Cellulose Gum (tree pulp/cotton seed), Natural Flavor, Cocamidopropyl Betaine (coconut-derived), Stevia Rebaudiana Leaf Extract (stevia). All inactive ingredients are described in the format \"ingredient name (source)\"."],"indications_and_usage":["Use aids in the prevention of dental decay"],"keep_out_of_reach_of_children":["Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M021"],"brand_name":["Orajel Gabbys Dollhouse"],"generic_name":["SODIUM FLUORIDE"],"is_original_packager":[true],"manufacturer_name":["Church & Dwight Co., Inc."],"package_ndc":["10237-914-42"],"product_ndc":["10237-914"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["416783"],"spl_id":["703c32bc-8273-4875-83fe-bd7c29583f95"],"spl_set_id":["cd47bd1e-44ac-465f-8529-6073ade14706"],"substance_name":["SODIUM FLUORIDE"],"unii":["8ZYQ1474W7"],"upc":["0310310240004"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 119 g Tube Label DREAMWORKS GABBY'S DOLLHOUSE STAGE 2 0-3 YEARS Orajel ™ kids NATURALLY SOURCED* anti • cavity TOOTHPASTE fluoride NATURAL FRUITY BUBBLE OUR COMMITMENT CERTIFIED RENEWABLE ENERGY Green-e ® PROUD SUPPORTER OF Arbor Day Foundation ® PLASTIC TUBE how2recycle.info SCAN ME NET WT 4.2 OZ (119 g) PRINCIPAL DISPLAY PANEL - 119 g Tube Label"],"purpose":["Purpose Anticavity"],"questions":["Questions or comments? Call us at 1-800-952-5080 M-F 9am-5pm ET or visit our website at orajelkids.com"],"set_id":"cd47bd1e-44ac-465f-8529-6073ade14706","spl_product_data_elements":["Orajel Gabbys Dollhouse Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION SORBITOL WATER HYDRATED SILICA GLYCERIN CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED COCAMIDOPROPYL BETAINE STEVIA REBAUDIUNA LEAF"],"spl_unclassified_section":["Drug Facts"],"version":"1","warnings":["Warnings Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away."]}