{"active_ingredient":["Active ingredients Benzocaine 20% Menthol 0.26% Zinc chloride 0.15%"],"do_not_use":["Do not use","Do not use more than directed for more than 7 days unless directed by a dentist or doctor for teething in children under 2 years of age"],"dosage_and_administration":["Directions Adults and children 2 years of age and older Apply to affected area up to 4 times daily or as directed by a dentist or doctor Children between 2 and 12 years of age Ask a doctor before use. Should be supervised in the use of this product Children under 2 years of age Do not use"],"effective_time":"20230120","id":"6eb4fc21-aa24-44ff-bc5e-b43e92a47301","inactive_ingredient":["Inactive ingredients ammonium glycyrrhizate, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid, water"],"indications_and_usage":["Use for the temporary relief of pain due to minor irritation or injury of the mouth and gums"],"keep_out_of_reach_of_children":["Keep out of reach of children In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away"],"openfda":{"application_number":["M022"],"brand_name":["Orajel Gum Pain 3X Medicated"],"generic_name":["BENZOCAINE, MENTHOL, ZINC CHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Church & Dwight Co., Inc."],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["10237-792-12","10237-792-42"],"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":["10237-792"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["2362013"],"spl_id":["6eb4fc21-aa24-44ff-bc5e-b43e92a47301"],"spl_set_id":["9a1632ad-2b47-5653-e053-2995a90ae0d9"],"substance_name":["BENZOCAINE","ZINC CHLORIDE","MENTHOL, UNSPECIFIED FORM"],"unii":["U3RSY48JW5","86Q357L16B","L7T10EIP3A"]},"other_safety_information":["Other information do not use if Tamper-Evident Tab is open before first use"],"package_label_principal_display_panel":["Principal Display Panel #1 ORAL PAIN RELIEVER BRAND FOR ADULTS Open Tube Tip Orajel GUM PAIN 3X MEDICATED GEL INSTANT PAIN RELIEF 20% Benzocaine to Relieve Gum Pain Cooling Relief to Soothe Gums Relieves Gum Irritation ORAL PAIN RELIEVER/ASTRINGENT NET WT 0.125oz (3.5g) CR2_DA2044058_OJFC-00500-01_72016656"],"purpose":["Purpose Oral pain reliever and Oral astringent"],"questions":["Questions or comments? call us at 1-800-952-5080 M-F 9am-5pm ET or visit our website at www.orajel.com"],"set_id":"9a1632ad-2b47-5653-e053-2995a90ae0d9","spl_product_data_elements":["Orajel Gum Pain 3X Medicated benzocaine, menthol, zinc chloride BENZOCAINE BENZOCAINE ZINC CHLORIDE ZINC CATION MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM WATER POLYETHYLENE GLYCOL 400 METHYL SALICYLATE SACCHARIN SODIUM SORBIC ACID PEG-75 LANOLIN AMMONIUM GLYCYRRHIZATE"],"stop_use":["Stop use and ask a doctor if symptoms do not improve in 7 days swelling, rash or fever develops irritation, pain or redness persists or worsens"],"version":"3","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 in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: pale, gray, or blue colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or lightheadedness, fatigue or lack of energy Allergy alert : do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other \"caine\" anesthetics"]}