{"active_ingredient":["Active ingredient Sodium monofluorophosphate 0.76% (0.14% w/v fluoride ion)"],"dosage_and_administration":["Directions • adults and children 2 years of age and older: o apply toothpaste onto a toothbrush o brush teeth thoroughly, preferable after each meal or at least twice a day, and not more than 3 times a day, or as directed by a dentist or doctor. Minimizing swallowing. Spit out after brushing. o to minimize swallowing for children under 6 years of age, use a pea-sized amoun and supervise brushing and rinsing until good habits are established. • children under 2 years of age: Consult a dentist or doctor."],"effective_time":"20241104","id":"c26f08a5-fa67-417e-8499-015edb65f7f8","inactive_ingredient":["Inactive ingredients sorbitol, glycerin, calcium pyrophosphate, water, hydrated silica, xylitol, silica, hydroxyethyl cellulose, isoceteth-20, cellulose gum, flavor, sodium benzoate, sodium lactate."],"indications_and_usage":["Use aids in the prevention of dental cavities."],"keep_out_of_reach_of_children":["Keep out of reach of children under 6 years of age. If more than used for bushing is accidentally swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M022"],"brand_name":["biotene"],"generic_name":["SODIUM MONOFLUOROPHOSPHATE"],"is_original_packager":[true],"manufacturer_name":["Haleon US Holdings LLC"],"package_ndc":["0135-0577-01"],"product_ndc":["0135-0577"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["545626"],"spl_id":["c26f08a5-fa67-417e-8499-015edb65f7f8"],"spl_set_id":["a47a6502-efb2-4072-9562-cbe293531c2b"],"substance_name":["SODIUM MONOFLUOROPHOSPHATE"],"unii":["C810JCZ56Q"]},"package_label_principal_display_panel":["Principal Display Panel NDC 0135-0577-01 biotene ® Fluoride Toothpaste SPECIALLY FORMULATED TO NOT IRRITATE Helps prevent cavities & strengthen teeth Gentle Formula GENTLE MINT NET WT 4.3 OZ (121.9g) 1000114 Front Carton Biotene Gentle Mint Original 4.3 oz (121.9g)"],"purpose":["Purpose Anticavity"],"questions":["Questions or comments? Call toll-free 1-800-922-5856"],"set_id":"a47a6502-efb2-4072-9562-cbe293531c2b","spl_product_data_elements":["biotene sodium monofluorophosphate SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION SORBITOL GLYCERIN CALCIUM PYROPHOSPHATE WATER HYDRATED SILICA XYLITOL SILICON DIOXIDE HYDROXYETHYL CELLULOSE, UNSPECIFIED ISOCETETH-20 XANTHAN GUM SODIUM BENZOATE CALCIUM LACTATE ANHYDROUS"],"spl_unclassified_section":["Additional information This product contains no Sodium Lauryl Sulfate (SLS) Trademarks are owned by or licensed to the GSK group of companies. Distributed by: GSK Consumer Healthcare Warren, NJ 07059 @2019 GSK group of companies or its licensor. Questions or Comments? 1-800-922-5856"],"storage_and_handling":["Other information store at or below 25ºC (77ºF)"],"version":"9","warnings":["Warnings When using this product, if irritation occurs discontinue use. Keep out of reach of children under 6 years of age. If more than used for bushing is accidentally swallowed, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product, if irritation occurs discontinue use."]}