{"active_ingredient":["Active Ingredient Purpose Benzocaine 20%................................Oral pain reliever"],"do_not_use":["Do not use more than directed for more than 7 days unless directed by a doctor for teething in children under 2 years of age"],"dosage_and_administration":["Distributed by CDMA, INC Novi, MI 48375 Made in China"],"effective_time":"20251016","id":"414fb186-8272-58da-e063-6394a90a7ac6","inactive_ingredient":["Inactive ingredient glycerin, peppermint oil, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium, sorbitol"],"indications_and_usage":["Directions Adults and children 2 years of age and older Remove cap and cut tip of tube. Apply a small amount of product to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctor. Children under 12 years of age Should be supervised in the use of this product Children under 2 years of age Do not use"],"indications_and_usage_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td>Adults and children 2 years of age and older</td><td>Remove cap and cut tip of tube. Apply a small amount of product to the cavity and around gum surrounding the teeth. Use up to 4 times daily or as directed by a dentist or doctor.</td></tr><tr><td>Children under 12 years of age</td><td>Should be supervised in the use of this product</td></tr><tr><td>Children under 2 years of age</td><td>Do not use</td></tr></tbody></table>"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose or allergic reaction, seek medical help or contact a Poison Control Center (1-800-222-1222) right away."],"openfda":{"application_number":["M022"],"brand_name":["Quality Choice"],"generic_name":["BENZOCAINE"],"is_original_packager":[true],"manufacturer_name":["Chain Drug Marketing Association, Inc."],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["83324-299-42"],"pharm_class_cs":["Allergens [CS]"],"pharm_class_epc":["Standardized Chemical Allergen [EPC]"],"pharm_class_pe":["Increased Histamine Release [PE]","Cell-mediated Immunity [PE]"],"product_ndc":["83324-299"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["238910"],"spl_id":["414fb186-8272-58da-e063-6394a90a7ac6"],"spl_set_id":["24c3c4a3-bd76-198d-e063-6394a90ad45a"],"substance_name":["BENZOCAINE"],"unii":["U3RSY48JW5"],"upc":["0635515953628"]},"package_label_principal_display_panel":["95362"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Uses for the temporary relief of pain due for: toothache canker sores gum pain denture pain cheek bites"],"set_id":"24c3c4a3-bd76-198d-e063-6394a90ad45a","spl_product_data_elements":["Quality Choice Benzocaine BENZOCAINE BENZOCAINE PEPPERMINT OIL POLYETHYLENE GLYCOL 4000 GLYCERIN POLYETHYLENE GLYCOL 400 SACCHARIN SODIUM SORBITOL"],"stop_use":["Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days irritation, pain or redness does not go away swelling, rash or fever develops"],"storage_and_handling":["Other information store at room temperature 20-25º (68-77ºF) this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist or doctor can be consulted. Do not use continuously."],"version":"4","warnings":["Warnings Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried blood. This can occur even I you have used this product before. Stop use and seek immediate medical attention if you are a child in your care develops: pale, gay, or blue colored skin (cyanosis) headache rapid heart rate shortness of breath dizziness or lightheartedness fatigue or lack of energy ​Allergy Alert: do not use this product if you have a history of allergy to local anethetics as procaine, bucaine, benzocaine or other \"caine\" anesthetics."]}