{"active_ingredient":["Active ingredients Benzalkonium chloride 0.02% Benzocaine 20% Menthol 0.26% Zinc chloride 0.15%"],"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 3 years of age"],"dosage_and_administration":["Directions adults and children 3 years of age and older apply to affected area up to 4 times daily or as directed by a dentist or doctor children between 3 and 12 years of age should be supervised in the use of this product children under 3 years of age do not use"],"effective_time":"20260831","id":"5a1c7fdc-8ac7-d3b8-e063-6294a90a63c0","inactive_ingredient":["Inactive ingredients ammonium glycyrrhizate, flavor, PEG-8, PEG-75, raspberry ketone, sodium saccharin, sorbic acid, titanium dioxide, water"],"indications_and_usage":["Uses first aid to help prevent infection in minor oral irritation for the temporary relief of pain due to minor irritation or injury of the mouth and gums occasional sore mouth and sore throat"],"keep_out_of_reach_of_children":["Keep out of reach of children If more than used for pain relief is accidentally swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M022"],"brand_name":["Orajel 4X Medicated Toothache and Gum Cream"],"generic_name":["BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Church & Dwight Co., Inc."],"nui":["N0000185508","N0000175629","N0000184306","M0000728","N0000175530","N0000175529"],"package_ndc":["10237-888-33"],"pharm_class_cs":["Allergens [CS]"],"pharm_class_epc":["Standardized Chemical Allergen [EPC]","Copper Absorption Inhibitor [EPC]"],"pharm_class_pe":["Increased Histamine Release [PE]","Cell-mediated Immunity [PE]","Decreased Copper Ion Absorption [PE]"],"product_ndc":["10237-888"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["2751338"],"spl_id":["5a1c7fdc-8ac7-d3b8-e063-6294a90a63c0"],"spl_set_id":["5a1c82b4-02b3-d456-e063-6294a90a16bb"],"substance_name":["BENZALKONIUM CHLORIDE","BENZOCAINE","MENTHOL, UNSPECIFIED FORM","ZINC CATION"],"unii":["F5UM2KM3W7","U3RSY48JW5","L7T10EIP3A","13S1S8SF37"],"upc":["0310310000271"]},"other_safety_information":["Other information do not use if Tamper-Evident Tab is open before first use avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying"],"package_label_principal_display_panel":["Principal Display Panel #1 ORAL PAIN RELIEF BRAND FOR ADULTS OUR MAXIMUM STRENGTH Orajel 4X MEDICATED TOOTHACHE & GUM IMMEDIATE RELIEF OF SEVERE PAIN Provides Long-Lasting Pain Relief* Helps Prevent Infection & Kills Harmful Bacteria Relieves Throbbing Pain Delivers Targeted Pain Relief ORAL ANTISEPTIC/PAIN RELIEVER/ASTRINGENT NET WT 0.33 OZ (9.4 g) Orajel 4X CREAM"],"purpose":["Purpose Oral antiseptic, Oral pain reliever, 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":"5a1c82b4-02b3-d456-e063-6294a90a16bb","spl_product_data_elements":["Orajel 4X Medicated Toothache and Gum Cream Benzalkonium chloride, Benzocaine, Menthol, Zinc chloride BENZALKONIUM CHLORIDE BENZALKONIUM BENZOCAINE BENZOCAINE MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM ZINC CATION ZINC CATION SACCHARIN SODIUM POLYETHYLENE GLYCOL 400 PEG-75 LANOLIN SORBIC ACID TITANIUM DIOXIDE AMMONIUM GLYCYRRHIZATE WATER RASPBERRY KETONE"],"stop_use":["Stop use and ask a doctor if sore throat is severe, persists for more than 2 days sore mouth symptoms do not improve in 7 days headache, nausea, vomiting, swelling, rash or fever develops irritation, pain or redness persists or worsens"],"version":"1","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"]}