{"active_ingredient":["Active ingredient Sodium Fluoride (0.15% w/v fluoride ion)"],"dosage_and_administration":["Directions Adults and children over 12 years • apply toothpaste onto a soft bristle toothbrush • brush thoroughly after meals or at least twice a day or use as directed by a dentist or physician. Children 12 years and under ask a dentist or physician. Once recommended, to minimize swallowing for children under 6, use a pea-sized amount and supervise brushing until good habits are established."],"effective_time":"20241105","id":"95462fd1-5eb4-46ff-bf63-a5e610337bc6","inactive_ingredient":["Inactive ingredients (Fresh Mint Original) Water, Sorbitol, Hydrated Silica, Glycerin, PEG-8, Cocamidopropyl Betaine, Xanthan Gum, Flavor, Sodium Saccharin, Sucralose, Titanium Dioxide, Sodium Hydroxide","Inactive ingredients (Gentle Mint) Water, Sorbitol, Hydrated Silica, Glycerin, PEG-8, Cocamidopropyl Betaine, Xanthan Gum, Flavor, Sodium Saccharin, Sucralose, Sodium Hydroxide, D&C Yellow #10, FD&C Blue #1"],"indications_and_usage":["Use aids in the prevention of dental cavities"],"keep_out_of_reach_of_children":["Keep out of reach of children 12 years of age and under (Fresh Mint and Gentle Mint) If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away. Do not use if you are allergic to any of the ingredients.","Keep out of reach of children 12 years of age and under. (PBF) If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away. If symptoms of a dry mouth persist, consult a healthcare professional. Do not use if you are allergic to any of the ingredients."],"openfda":{"application_number":["M022"],"brand_name":["BIOTENE Fresh Mint Original","BIOTENE Gentle Mint"],"generic_name":["SODIUM FLUORIDE"],"is_original_packager":[true],"manufacturer_name":["Haleon US Holdings LLC"],"package_ndc":["0135-0557-01","0135-0557-02","0135-0558-01"],"product_ndc":["0135-0557","0135-0558"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["416783","1044547"],"spl_id":["95462fd1-5eb4-46ff-bf63-a5e610337bc6"],"spl_set_id":["1101c17f-c848-4cd5-a7cd-679b59dbe1bf"],"substance_name":["SODIUM FLUORIDE"],"unii":["8ZYQ1474W7"]},"package_label_principal_display_panel":["Principal Display Panel NDC 0135-0557-01 biotene ® FLUORIDE TOOTHPASTE GENTLE FORMULA SPECIALLY FORMULATED TO NOT IRRITATE FRESH MINT ORIGINAL NET WT 4.3 OZ (121.9g) FROM THE MAKERS OF BIOTENE #1 DENTIST & HYGIENTIST RECOMMENDED BRAND FOR DRY MOUTH SYMPTOMS HELPS MAINTAIN ORAL ENVIRONMENT • HELPS FRESHEN BAD BREATH • SLS FREE • BALANCED PH • GENTLE FORMULA • ESSENTIAL FLUORIDE TOOTH PROTECTION Also look for other biotene ® products including biotene ® Oral Rinses, biotene ® oralbalance Gel, and biotene ® Mouth Spray. ALWAYS FOLLOW THE LABEL This product contains no Sodium Lauryl Sulfate (SLS) Biotene, oralbalance and graphic elements are trademarks of the GSK group of companies. www.biotene.com Distributed by: GlaxoSmithKline Consumer Healthcare, L.P. Moon Township, PA 15108 ©2014 GSK 102875XC Biotene Fresh Mint Original 4.3 oz (121.9) carton","Principal Display Panel NDC 0135-0558-01 biotene ® FLUORIDE TOOTHPASTE GENTLE FORMULA SPECIALLY FORMULATED TO NOT IRRITATE GENTLE MINT NET WT 4.3 OZ (121.9g) FROM THE MAKERS OF BIOTENE #1 DENTIST & HYGIENTIST RECOMMENDED BRAND FOR DRY MOUTH SYMPTOMS HELPS MAINTAIN ORAL ENVIRONMENT • HELPS FRESHEN BAD BREATH • SLS FREE • BALANCED PH • GENTLE FORMULA • ESSENTIAL FLUORIDE TOOTH PROTECTION Also look for other biotene ® products including biotene ® Oral Rinses, biotene ® oralbalance Gel, and biotene ® Mouth Spray. ALWAYS FOLLOW THE LABEL This product contains no Sodium Lauryl Sulfate (SLS) Biotene, oralbalance and graphic elements are trademarks of the GSK group of companies. Distributed by: GlaxoSmithKline Consumer Healthcare, L.P. Moon Township, PA 15108 ©2014 GSK 102874XC Biotene Gentle Mint Original 4.3 oz (121.9g) carton"],"purpose":["Purpose Anticavity"],"questions":["Questions or comments? call toll-free 1-800-922-5856 weekdays"],"set_id":"1101c17f-c848-4cd5-a7cd-679b59dbe1bf","spl_product_data_elements":["BIOTENE Fresh Mint Original sodium fluoride SODIUM FLUORIDE FLUORIDE ION WATER SORBITOL HYDRATED SILICA GLYCERIN POLYETHYLENE GLYCOL 400 COCAMIDOPROPYL BETAINE XANTHAN GUM SACCHARIN SODIUM SUCRALOSE TITANIUM DIOXIDE SODIUM HYDROXIDE Fresh Mint BIOTENE Gentle Mint sodium fluoride SODIUM FLUORIDE FLUORIDE ION WATER SORBITOL HYDRATED SILICA GLYCERIN POLYETHYLENE GLYCOL 400 COCAMIDOPROPYL BETAINE XANTHAN GUM SACCHARIN SODIUM SUCRALOSE SODIUM HYDROXIDE D&C YELLOW NO. 10 FD&C BLUE NO. 1 Gentle Mint"],"storage_and_handling":["Other information store below 25°C (77F°)"],"version":"10","warnings":["Warnings Keep out of reach of children 12 years of age and under (Fresh Mint and Gentle Mint) If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away. Do not use if you are allergic to any of the ingredients. Keep out of reach of children 12 years of age and under. (PBF) If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away. If symptoms of a dry mouth persist, consult a healthcare professional. Do not use if you are allergic to any of the ingredients."]}