{"active_ingredient":["Active Ingredient 1.1% neutral sodium fluoride"],"dosage_and_administration":["Directions Use twice a day (morning and evening) in place of regular toothpaste or as recommended by a dentist or a physician. Adults and children 6 years of age and older. Twist off cap and remove foil seal. Apply at least a 1-inch strip of gel onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute. Spit out and rinse mouth thoroughly."],"effective_time":"20260108","id":"47e4ef9a-0514-2fe9-e063-6294a90a9b7f","inactive_ingredient":["Inactive Ingredients Water, Glycerin, Hydrated Silica, Calcium Carbonate, Xylitol, Sorbitol, Xanthan Gum, Flavor, Yucca Shidigera Root Extract, Quillaja Saponaria Bark Extract, Smilax Aristolochiaefolia Root Extract, Dioscorea Villosa Root Extract, Tocopheryl Acetate,Cocamidopropyl Betaine, Benzyl Alcohol."],"indications_and_usage":["Uses This is a fluoride dental gel intended for use as dental caries preventive in adults and pediatric patients."],"keep_out_of_reach_of_children":["Children under 6 Years of Age : Consult a dentist or physician."],"openfda":{},"package_label_principal_display_panel":["Product label image description"],"purpose":["Purpose Dental gel"],"set_id":"3e99214b-9fe6-4298-a572-b95a7f6c2f30","spl_product_data_elements":["FRAICHE 5000 DENTAL MINT SODIUM FLUORIDE WATER GLYCERIN HYDRATED SILICA CALCIUM CARBONATE XYLITOL SORBITOL XANTHAN GUM YUCCA SCHIDIGERA WHOLE QUILLAJA SAPONARIA BARK SMILAX ARISTOLOCHIIFOLIA ROOT DIOSCOREA VILLOSA ROOT .ALPHA.-TOCOPHEROL ACETATE COCAMIDOPROPYL BETAINE BENZYL ALCOHOL SODIUM FLUORIDE FLUORIDE ION"],"spl_unclassified_section":["Other information To report suspected adverse reactions, contact True Marker Pharmaceuticals at (877) 887-9879 or the FDA at (800) FDA-1088 or www.fda.gov/medwatch."],"version":"5","warnings":["Warnings Do not swallow. Keep out of reach of children. Read the prescribing information fully before using this product. If the product is accidentally swallowed in quantities greater than would normally occur with a toothpaste, seek medical help right away. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or physician. Contraindications : Avoid use in patients with known hypersensitivity to fluoride. Do not use in pediatric patients under 6 unless directed by a dentist or physician."]}