{"active_ingredient":["Active ingredient Purpose Menthol(0.1%)...... Oral pain reliever"],"dosage_and_administration":["Apply a small amount of gel to the affected area of the mouth. Gargle, swish around, or allow to remain in place at least 1 minute and then spit out. Use up to 4 times daily or as directed by a dentist or doctor."],"effective_time":"20260319","id":"4d6db039-5b98-8f3f-e063-6294a90a9d85","inactive_ingredient":["Inactive ingredients Polihexanide, Riboflavin, Ferrous Sulfate, Sorbitol, Sodium Alginate, Glycerin, Niacinamide, Carbomer Homopolymer, Trolamine, Water"],"indications_and_usage":["Directions Adults and children 2 years of ageand older: Apply a small amountof gel to the affected area of themouth. Gargle, swish around, orallow to remain in place at least 1minute and then spit out. Use upto 4 times daily or as directed by adentist or doctor.Children under 12 years of ageshould be supervised in the use of this product.Children under 2 years of age:Consult a dentist or doctor."],"keep_out_of_reach_of_children":["Keep out of reach of children"],"openfda":{"application_number":["M022"],"brand_name":["SmileCare Mouth Ulcer Gel"],"generic_name":["MENTHOL"],"is_original_packager":[true],"manufacturer_name":["Yantai Aien Biotechnology Co., Ltd."],"package_ndc":["87512-004-01","87512-004-02","87512-004-03"],"product_ndc":["87512-004"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"spl_id":["4d6db039-5b98-8f3f-e063-6294a90a9d85"],"spl_set_id":["4d6db039-5b97-8f3f-e063-6294a90a9d85"],"substance_name":["MENTHOL"],"unii":["L7T10EIP3A"]},"package_label_principal_display_panel":["87512-004-01 SmileCare Mouth Ulcer Gel 10g 87512-004-01","87512-004-02 SmileCare Mouth Ulcer Gel 15g 87512-004-02","87512-004-03 SmileCare Mouth Ulcer Gel 20g 87512-004-03"],"purpose":["Uses Temporarily relieves occasional minor irritation and pain associated with sore mouth and sore throat."],"set_id":"4d6db039-5b97-8f3f-e063-6294a90a9d85","spl_product_data_elements":["SmileCare Mouth Ulcer Gel Menthol SODIUM ALGINATE GLYCERIN MENTHOL MENTHOL RIBOFLAVIN TROLAMINE WATER CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE NIACINAMIDE POLIHEXANIDE SORBITOL FERROUS SULFATE"],"version":"1","warnings":["Warnings Do not use In children under 2 years of age unless directed by a doctor Sore throat warnings 1If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. These may be serious."]}