{"active_ingredient":["Benzocaine 20% White petrolatum 73.64%"],"do_not_use":["Do not use more than directed for more than 7 days unless directed by a physician or healthcare provider for teething in children under 2 years of age"],"dosage_and_administration":["Directions cut open tube of tip on score mark Do not use if tip is cut prior to opening Adults and Children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily Children betweem 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":"20251205","id":"45382973-75d6-bf98-e063-6294a90a50fc","inactive_ingredient":["Inactive ingredients cholecalciferol, mineral oil, phenoxyethanol (and) hydroxyacetophenone (and) caprylyl glycol (and) water, propylene glycol, prunella vulgaris leaf extract, retinyl palmitate (vitamin A palmitate), tocopherol, tocopherol acetate (vitamin E acetate), zea mays (corn) oil"],"indications_and_usage":["Use temporarily relieves pain, itching and dryness; softens crusts (scabs) associated with • cold sores • fever blisters"],"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":["M017"],"brand_name":["Orajel for Cold Sores Double Medicated, Cream"],"generic_name":["BENZOCAINE AND WHITE PETROLATUM"],"is_original_packager":[true],"manufacturer_name":["Church & Dwight Co., Inc."],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["10237-797-12"],"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":["10237-797"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"spl_id":["45382973-75d6-bf98-e063-6294a90a50fc"],"spl_set_id":["b8699a40-8464-ca02-e053-2995a90a4260"],"substance_name":["BENZOCAINE","PETROLATUM"],"unii":["U3RSY48JW5","4T6H12BN9U"]},"package_label_principal_display_panel":["#1 ORAL PAIN RELIVER BRAND FOR ADULTS 2 Active Ingredients Orajel Instant Pain Relief FOR COLD SORES Fast-Acting Cream DOUBLE MEDICATED Relieves Pain & Itching Moisturizing Barrier Stays in Place Paraben Free TOPICAL ANESTHETIC/SKIN PROTECTANT NET WT 0.125 OZ (3.5 g) Label.jpg"],"purpose":["Topical anesthetic Skin protectant"],"questions":["Questions or comments? call us at 1-800-952-5080 M-F 9am-5pm or visit our website at www.orajel.com"],"set_id":"b8699a40-8464-ca02-e053-2995a90a4260","spl_product_data_elements":["Orajel for Cold Sores Double Medicated, Cream Benzocaine and White Petrolatum CHOLECALCIFEROL METHYLPARABEN MINERAL OIL POLYETHYLENE GLYCOL, UNSPECIFIED PRUNELLA VULGARIS FLOWERING TOP VITAMIN A PALMITATE .ALPHA.-TOCOPHEROL .ALPHA.-TOCOPHEROL ACETATE, D- WATER CORN OIL BENZOCAINE BENZOCAINE PETROLATUM PETROLATUM"],"version":"5","warnings":["Warnings For external use only 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"]}