{"active_ingredient":["Active ingredients Benzalkonium chloride Benzocaine"],"ask_doctor":["Ask a physician if •used to treat deep or puncture wounds, animal bites or serious burns •you are pregnant or nursing a baby"],"do_not_use":["Do not use •in the eyes •over large areas of the body •if you are allergic to any ingredient in this product •more than 3 times per day •longer than 1 week unless directed by a physician •for teething •in children under 2 years of age"],"dosage_and_administration":["Directions •slide-off to remove the protective blue paper cover and slide it on the other end - opposite the white applicator tip •squeeze the vial firmly on the arrow shown on the blue paper cap until you hear it snap •hold with the white applicator tip down to allow the medication to saturate the tip •to minimize pain during application gently touch the site of the cold sore with the saturated applicator tip •Once the area is numb, rub the site of the cold sore and the surrounding area. Rub firmly to allow the treatment to deeply penetrate the skin •to treat most cold sores, multiple treatments may be required •discard after use •for best result ensure that lip area is free of lip preparations, lotions, ointments, residual beverages, or cosmetics, including lipstick Adults and children 2 years of age and older Do not use more than 3 times per day 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":["
Adults and children 2 years of age and olderDo not use more than 3 times per day
Children between 2 and 12 years of ageAsk a doctor before use. Should be supervised in the use of this product
Children under 2 years of ageDo not use
"],"effective_time":"20260513","id":"51b6fb8e-eeba-a04a-e063-6294a90a610f","inactive_ingredient":["Inactive ingredients isopropyl alcohol (70% v/v), water"],"indications_and_usage":["Uses to treat cold sores/fever blisters"],"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":["M017"],"brand_name":["Orajel Cold Sore Touch Free - Single Dose"],"generic_name":["BENZALKONIUM CHLORIDE, BENZOCAINE"],"is_original_packager":[true],"manufacturer_name":["Church & Dwight Co., Inc."],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["10237-798-35"],"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":["10237-798"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["2572114"],"spl_id":["51b6fb8e-eeba-a04a-e063-6294a90a610f"],"spl_set_id":["ce40829e-941f-2548-e053-2995a90a1e0e"],"substance_name":["BENZALKONIUM CHLORIDE","BENZOCAINE"],"unii":["F5UM2KM3W7","U3RSY48JW5"],"upc":["0310310998943"]},"other_safety_information":["Other information •store at room temperature • the ingredients in toothpaste, soft drinks, and some fruit juices can deactivate the active ingredient in this product • for best results, avoid brushing your teeth with toothpaste or drinking soft drinks or fruit juices for at least one hour after applying the drug •do not use if package is torn, cut or otherwise damaged"],"package_label_principal_display_panel":["NEW LOOK #1 ORAL PAIN RELIEF BRAND FOR ADULTS BONUS 50% MORE Orajel™ COLD SORE PROVIDES IMMEDIATE, TARGETED PAIN RELIEF LIQUID FORMULA TOPICAL ANTISEPTIC TOPICAL ANESTHETIC CONTAINS 6 TREATMENT VIALS NET 0.12 FL OZ (3.5 mL) TOTAL Orajel Touch Free Cold Sore - Six Vials.jpg"],"purpose":["Purpose Benzalkonium chloride 0.13% ...................................................Topical Antiseptic Benzocaine 5% .........................................................................Topical Anesthetic"],"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":"ce40829e-941f-2548-e053-2995a90a1e0e","spl_product_data_elements":["Orajel Cold Sore Touch Free - Single Dose Benzalkonium Chloride, Benzocaine WATER ISOPROPYL ALCOHOL BENZALKONIUM CHLORIDE BENZALKONIUM BENZOCAINE BENZOCAINE"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a dentist or physician if •condition persists or worsens •symptoms persist for more than 7 days"],"version":"6","warnings":["Warnings For external use only. Flammable, keep away from fire or flame. 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 Do not use •in the eyes •over large areas of the body •if you are allergic to any ingredient in this product •more than 3 times per day •longer than 1 week unless directed by a physician •for teething •in children under 2 years of age Stop use and ask a dentist or physician if •condition persists or worsens •symptoms persist for more than 7 days Ask a physician if •used to treat deep or puncture wounds, animal bites or serious burns •you are pregnant or nursing a baby When using this product you may feel a brief stinging when you apply it. The sting should go away in a short time. Keep out of reach of children. In case of overdose, or allergic reaction, get medical help or contact a Poison Control Center right away"],"when_using":["When using this product you may feel a brief stinging when you apply it. The sting should go away in a short time."]}