{"active_ingredient":["Benzalkonium chloride 0.13% ... Oral antiseptic Benzocaine 20% .... Oral pain reliever Menthol 0.5% .... Oral pain reliever Zinc chloride 0.15% ....Oral astringent"],"do_not_use":["Do not use * more than directed * for more than 7 days unless told to do so by a dentist or doctor * for teething * in children under 2 years of age"],"dosage_and_administration":["Directions Directions * cut open tip of tube on score mark * adults and children 2 years of age and older: apply a small amount product to the cavity and around the 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 teh use of this product * children under 2 years of age: do not use"],"effective_time":"20251113","id":"437fd35c-d085-cbb8-e063-6394a90a1c11","inactive_ingredient":["Inactive ingredients ammonium glycyrrhizate, blue 1, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid"],"indications_and_usage":["Directions Directions * cut open tip of tube on score mark * adults and children 2 years of age and older: apply a small amount product to the cavity and around the 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 teh use of this product * children under 2 years of age: do not use"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M022"],"brand_name":["4X Medicated Toothache and Gum Gel"],"generic_name":["BENZOCAINE"],"is_original_packager":[true],"manufacturer_name":["Walmart"],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["49035-569-99"],"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":["49035-569"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["2369638"],"spl_id":["437fd35c-d085-cbb8-e063-6394a90a1c11"],"spl_set_id":["a471a858-edbf-c31e-e053-2995a90a7156"],"substance_name":["BENZOCAINE","ZINC CHLORIDE","BENZALKONIUM CHLORIDE","MENTHOL"],"unii":["U3RSY48JW5","86Q357L16B","F5UM2KM3W7","L7T10EIP3A"]},"other_safety_information":["Other information * do not use if tip is cut prior to opening * this preparation is intended for use in cases of toothache, only as a temporary expedient untill a dentist can be consulted * do not use continuously * this formula will stay in place for extended duration of relief * avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying"],"package_label_principal_display_panel":["4x Medicated Toothache & Gum Relief Gel *20'% Benzocaine to relieve oral pain *Kills harmful bacteria *Astringent to help prevent infection *Cools gumm and relieves irritation Fast Acting Gel Compare to Orajel 4x Medicated for Toothache and Gum Gel Active Ingredients Carton Artwork"],"purpose":["Use * for the temporary relief of pain due to toothaches * to help protect against infection of minor oral irritation"],"set_id":"a471a858-edbf-c31e-e053-2995a90a7156","spl_product_data_elements":["4X Medicated Toothache and Gum Gel Benzocaine BENZOCAINE BENZOCAINE ZINC CHLORIDE ZINC CATION SORBIC ACID FD&C BLUE NO. 1 AMMONIUM GLYCYRRHIZATE GLYCYRRHIZIN BENZALKONIUM CHLORIDE BENZALKONIUM MENTHOL MENTHOL POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 3350 SACCHARIN SODIUM SACCHARIN METHYL SALICYLATE"],"stop_use":["Stop use and ask a doctor if * swelling, rash or fever develops * irritation, pain or redness persists or worsens * symptoms do not improve in 7 days * allergic reaction occurs"],"version":"6","warnings":["Methemoglobinemia warning: use of this product may cause methoglobinemia, 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 immeditate 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 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 Do not use * more than directed * for more than 7 days unless told to do so by a dentist or doctor * for teething * in children under 2 years of age Stop use and ask a doctor if * swelling, rash or fever develops * irritation, pain or redness persists or worsens * symptoms do not improve in 7 days * allergic reaction occurs Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.","Allergy alert 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"]}