{"active_ingredient":["Benzalkonium chloride 0.13% Benzocaine 20% Menthol 0.5% 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 2 years of age"],"dosage_and_administration":["Directions cut open tip of tube on score mark adults and children 2 years of age and older: apply a small amount of 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 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 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 until 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"],"effective_time":"20260108","id":"47e5dd07-fa98-97e1-e063-6394a90ae6a6","inactive_ingredient":["ammonium glycyrrhizate, blue 1, flavor, PEG-8, PEG-75, sodium saccharin, sorbic acid"],"indications_and_usage":["temporary relief of pain due to toothache * to help protect against infection of minor oral irritation"],"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":["4x Medicated Toothache and Gum Gel"],"generic_name":["BENZOCAINE"],"is_original_packager":[true],"manufacturer_name":["Publix Super Markets INC"],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["56062-312-22"],"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":["56062-312"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["2369638"],"spl_id":["47e5dd07-fa98-97e1-e063-6394a90ae6a6"],"spl_set_id":["16eb9d15-dba3-36e6-e063-6394a90ab859"],"substance_name":["BENZOCAINE","BENZALKONIUM CHLORIDE","ZINC CHLORIDE","MENTHOL"],"unii":["U3RSY48JW5","F5UM2KM3W7","86Q357L16B","L7T10EIP3A"]},"package_label_principal_display_panel":["PUBLIX SUPER MARKETS, INC 4X MEDICATED GEL TOOTHACHE & GUM PAIN RELIEF 20% Benzocaine to relieve oral pain Kills harmful bacteria Astringent to help prevent infection Cools gum & relieves irritation Compare to the active ingredients in Orajel 4X medicated for toothache & Gum gel* NET WT 0.25OZ (7 g) Publix 4X Medicated Toothache & Gum Gel"],"purpose":["Oral antiseptic Oral pain reliever Oral astringent"],"set_id":"16eb9d15-dba3-36e6-e063-6394a90ab859","spl_product_data_elements":["4x Medicated Toothache and Gum Gel Benzocaine FD&C BLUE NO. 1 BENZOCAINE BENZOCAINE SORBIC ACID BENZALKONIUM CHLORIDE BENZALKONIUM POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 400 METHYL SALICYLATE SACCHARIN SODIUM ZINC CHLORIDE ZINC CATION AMMONIUM GLYCYRRHIZATE MENTHOL MENTHOL blue to Blue Green"],"spl_unclassified_section":["Drug Facts","DISTRIBUTED BY: PUBLIX SUPER MARKETS, 3300 PUBLIX CORPORATE PARKWAY LAKELAND, FL 33811"],"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 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 lightheadness fatique or lack of energy Alergy 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"]}