{"active_ingredient":["Active Ingredient Benzoin"],"dosage_and_administration":["Directions Adults and children 6 months of age and older: Dry the affected area, with cotton swab, apply undiluted to the affected area not more often than every 2 hours. Children under 6 months of age: Consult a dentist or doctor."],"effective_time":"20251211","id":"45b3d3ef-3410-79a1-e063-6394a90a758d","inactive_ingredient":["Inactive Ingredients Alcohol 77%, Aloe, Storax, Tolu Balsam"],"indications_and_usage":["Use Forms a coating over wound for protecting recurring canker sores"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately."],"openfda":{"application_number":["M022"],"brand_name":["Benzoin Compound Tincture"],"generic_name":["BENZOIN RESIN"],"is_original_packager":[true],"manufacturer_name":["Humco Holding Group, Inc."],"package_ndc":["0395-0243-16","0395-0243-92"],"product_ndc":["0395-0243"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"spl_id":["45b3d3ef-3410-79a1-e063-6394a90a758d"],"spl_set_id":["a893a232-2ea8-4e0d-8cbf-7f5040b3be2e"],"substance_name":["BENZOIN RESIN"],"unii":["GK21SBA74R"],"upc":["0303950243160","0303950243924"]},"other_safety_information":["Other information Flammable: Keep away from spark, heat or flame."],"package_label_principal_display_panel":["Principal Display Panel - 16oz Benz16.jpg 16 oz","Principal Display Panel - 2 oz Benz.jpg new label 2 oz","2025 Label Update Humco Benzoin Compound 2025"],"purpose":["Purpose Oral mucosal protectant"],"set_id":"a893a232-2ea8-4e0d-8cbf-7f5040b3be2e","spl_product_data_elements":["Benzoin Compound Tincture Benzoin Resin ALCOHOL ALOE TOLU BALSAM BENZOIN RESIN BENZOIN RESIN"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and consult a dentist or doctor if sore mouth symptoms do not improve in 7 days. irritation, pain or redness persists or worsens. swelling, rash or fever develops."],"version":"7","warnings":["Warnings For external use only. Do not swallow. Do not exceed recommended dosage."],"when_using":["When using this product Children under 12 years of age should be supervised in the use of this product. Do not use for more than 7 days unless directed by a dentist or doctor."]}