{"active_ingredient":["Benzocaine 20% Menthol 0.1% Zinc Chloride 0.15%"],"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 over 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"],"dosage_and_administration_table":["<table border=\"0\" width=\"100%\"><tbody><tr><td>Adults and children 2 years of age and over</td><td>Apply to affected area up to 4 times daily or as directed by a dentist or doctor</td></tr><tr><td>Children between 2 and 12 years of age</td><td>Ask a doctor before use. 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>"],"effective_time":"20251212","id":"45c2f5a1-7e8a-1fbd-e063-6394a90ab88f","inactive_ingredient":["allantoin, carbomer, disodium EDTA, flavor, polyethylene glycol, polysorbate 60, propylene glycol, pvp, sodium saccharin, sorbic acid, stearyl alcohol, water"],"indications_and_usage":["Use for the temporary relief of pain associated with canker sores, cold sores, fever blisters, minor irritation or injury of the mouth and gums"],"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 3X Medicated For All Mouth Sores"],"generic_name":["BENZOCAINE, MENTHOL, ZINC CHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Church & Dwight Co., Inc."],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["10237-783-18","10237-783-42","10237-783-12"],"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":["10237-783"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["2266762"],"spl_id":["45c2f5a1-7e8a-1fbd-e063-6394a90ab88f"],"spl_set_id":["99b589ac-9833-fb60-e053-2995a90a0935"],"substance_name":["BENZOCAINE","MENTHOL","ZINC CHLORIDE"],"unii":["U3RSY48JW5","L7T10EIP3A","86Q357L16B"]},"other_safety_information":["Other information do not use if Tamper-Evident Tab is open before first use"],"package_label_principal_display_panel":["#1 ORAL PAIN RELIEF BRAND FOR ADULTS EXTRA STRENGTH Orajel™ 3X MOUTH SORES MEDICATED IMMEDIATE PAIN RELIEF ORAL PAIN RELIEVER/ ASTRINGENT Provides Long-Lasting Pain Relief* Helps Protect Sores from Irritation Delivers Targeted Pain Relief GEL NET WT 0.18 OZ (5.1 g) Orajel 3x Gel - 31840.jpg"],"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":"99b589ac-9833-fb60-e053-2995a90a0935","spl_product_data_elements":["Orajel 3X Medicated For All Mouth Sores Benzocaine, Menthol, Zinc Chloride CARBOMER 934 POVIDONE SACCHARIN SODIUM SACCHARIN WATER EDETATE DISODIUM EDETIC ACID METHYL SALICYLATE POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL POLYSORBATE 60 SORBIC ACID STEARYL ALCOHOL ALLANTOIN BENZOCAINE BENZOCAINE MENTHOL MENTHOL ZINC CHLORIDE ZINC CATION"],"stop_use":["Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days swelling, rash or fever develops irritation, pain or redness persists or worsens"],"version":"5","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"]}